# US 2014/0207400 A1 · Method and Apparatus for Providing Data Processing and Control in a Medical Communication System

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- Number: US 2014/0207400 A1
- Document ID: US20140207400A1
- Status: Published application
- Kind: A1
- Application number: 14/223,893
- Filed: 2014-03-24
- Published: 2014-07-24
- Earliest claimed: 2007-05-14
- Assignees: Abbott Diabetes Care Inc.
- Applicants: Abbott Diabetes Care Inc.
- Inventors: Gary Alan Hayter; Geoffrey V. McGarraugh; Andrew H. Naegeli; John Charles Mazza; Benjamin Jay Feldman
- Web page: https://patentgrep.com/patent/US20140207400A1

## CPC

- G01N 33/49: Blood {(chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80)}
- A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement}
- A61B 5/1473: invasive, e.g. introduced into the body by a catheter
- A61B 5/1495: Calibrating or testing of in-vivo probes
- G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H 40/67: for remote operation
- A61B 2560/0223: of calibration, e.g. protocols for calibrating sensors
- A61B 2560/0252: using ambient temperature
- G16H 15/00: ICT specially adapted for medical reports, e.g. generation or transmission thereof
- G16H 40/40: for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
- G16H 50/50: for simulation or modelling of medical disorders
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Methods and apparatus for providing data processing and control for use in a medical communication system are provided.

## Claims

### Claim 1

A method, executed using one or more processors, of manufacturing analyte sensors, the method comprising:
determining a sensitivity value for each of a predetermined number of analyte sensors;
determining a sensitivity variation for the predetermined number of analyte sensors;
determining a mean sensitivity based on the sensitivity value determined for each of the predetermined number of analyte sensors when it is determined that a determined sensitivity variation does not exceed a tolerance threshold level; and
associating a sensor code with an analyte sensor batch associated with the predetermined number of analyte sensors when the mean sensitivity is within a predetermined sensitivity range.

### Claim 2 (depends on 1)

The method of claim 1, wherein the sensitivity variation is determined as a coefficient of variation.

### Claim 3 (depends on 1)

The method of claim 1, wherein the sensitivity value for each of the predetermined number of analyte sensors is determined in vitro.

### Claim 4 (depends on 3)

The method of claim 3, wherein the in vitro determination of the sensitivity value includes measuring the sensitivity value for each of the predetermined number of analyte sensors.

### Claim 5 (depends on 4)

The method of claim 4, wherein measuring the sensitivity value for each of the predetermined number of analyte sensors is performed during an analyte sensor manufacturing process.

### Claim 6 (depends on 1)

The method of claim 1, wherein the sensor code is used to calibrate the predetermined number of analyte sensors associated with the analyte sensor batch associated with the predetermined number of analyte sensors.

### Claim 7 (depends on 1)

The method of claim 1, wherein the sensor code is stored in an analyte monitoring device.

### Claim 8 (depends on 1)

The method of claim 1, further comprising determining a response time for each of the predetermined number of analyte sensors.

### Claim 9 (depends on 8)

The method of claim 8, further comprising determining a mean response time of the predetermined number of analyte sensors.

### Claim 10 (depends on 9)

The method of claim 9, wherein the mean response time is used for lag correction of data obtained using analyte sensors included in the analyte sensor batch associated with the predetermined number of analyte sensors.

### Claim 11 (depends on 1)

The method of claim 1, wherein each of the predetermined number of analyte sensors comprises a plurality of electrodes including a working electrode, wherein the working electrode comprises an analyte-responsive enzyme and a mediator, wherein at least one of the analyte-responsive enzyme and the mediator is chemically bonded to a polymer disposed on the working electrode, and wherein at least one of the analyte-responsive enzyme and the mediator is crosslinked with the polymer.

### Claim 12 (depends on 1)

The method of claim 1, wherein upon determining that the determined sensitivity variation exceeds the tolerance threshold level, rejecting the analyte sensor batch associated with the predetermined number of analyte sensors.

### Claim 13 (depends on 1)

The method of claim 1, wherein determining the sensitivity value for each of the predetermined number of analyte sensors further includes determining if each of the determined sensitivity values are within a predetermined range.

### Claim 14 (depends on 13)

The method of claim 13, further comprising rejecting the analyte sensor batch associated with the predetermined number of analyte sensors when a predetermined number of the determined sensitivity values are not within the predetermined range.

### Claim 15 (depends on 1)

The method of claim 1, wherein determining the mean sensitivity includes determining if the determined mean sensitivity is within the predetermined sensitivity range.

### Claim 16 (depends on 15)

The method of claim 15, further comprising rejecting the analyte sensor batch associated with the predetermined number of analyte sensors when the determined mean sensitivity is not within the predetermined sensitivity range.

### Claim 17 (depends on 1)

The method of claim 1, further including sampling the predetermined number of analyte sensors during an analyte sensor manufacturing process.

### Claim 18 (depends on 17)

The method of claim 17, wherein the sampled predetermined number of analyte sensors is a subset of the analyte sensors in the analyte sensor batch.
