| CPC A61B 5/1495 (2013.01) [A61B 5/14503 (2013.01); A61B 5/14532 (2013.01); A61B 5/14546 (2013.01); A61B 5/0002 (2013.01); A61B 2560/0223 (2013.01); A61B 2562/12 (2013.01); A61M 1/1603 (2014.02)] | 29 Claims |
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1. A method comprising:
physically associating with each of a first plurality of medical devices that comprise a lot, one or more identifiers that uniquely identifies the respective medical device of the first plurality, such that each respective medical device of the first plurality can be uniquely identifiable by the one or more identifiers associated with the respective medical device of the first plurality;
subjecting the first plurality of medical devices that were physically associated with the one or more respective identifiers to one or more manufacturing stages and, during at least one of the one or more manufacturing stages:
reading one or more of the identifiers physically associated with the respective medical device of the first plurality; and
obtaining one or more manufacturing parameters associated with the respective medical device of the first plurality;
storing the one or more obtained manufacturing parameters;
subjecting a second plurality of medical devices to one or more in vitro tests, wherein the second plurality is a first subset of the first plurality;
obtaining in vitro test data from one or more of the in vitro tests, and storing the in vitro test data;
determining, for a third plurality medical devices for which the one or more manufacturing parameters were stored, and based at least in part on the stored in vitro test data and one or more of the one or more stored manufacturing parameters associated with the respective medical device of the first plurality, individualized calibration information associated with the respective medical device of the first plurality, wherein the third plurality is a second subset of the first plurality;
for each of the third plurality of medical devices for which the individualized calibration information was determined:
reading one or more of the identifiers that were physically associated with the respective medical device of the third plurality;
retrieving, based at least in part on one or more of the identifiers that was read after determining the individualized calibration information associated with the respective medical device of the third plurality, the individualized calibration information associated with the respective medical device of the third plurality; and
wirelessly transmitting to an electronics unit associated with the respective medical device of the third plurality the retrieved individualized calibration information associated with the respective medical device of the third plurality, wherein after receipt by the electronics unit the individualized calibration information is stored in a non-transitory memory of the electronics unit, wherein:
the respective medical device of the third plurality is a transcutaneous electrochemical glucose sensor that comprises an ex vivo portion positionable above a skin surface of a user and an in vivo portion positionable below the skin surface to contact an interstitial fluid of the user to detect a plurality of glucose levels using a glucose-responsive enzyme; and
when the respective medical device of the third plurality is distributed to the user the respective medical device of the third plurality is integrated with the electronics unit and does not require user calibration.
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