BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3124024 · Received May 22, 2013

    Report

    Report Number
    2531779-2013-06862
    Event Type
    Injury
    Date Received
    May 22, 2013
    Report Date
    April 28, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN REQUESTED FOR RETURN TO ANIMAS. THERE WAS NO INDICATION OF A PUMP ISSUE RELATED TO THE EVENT. THE PATIENT ATTRIBUTED THE EVENT TO THE USE OF BAD INSULIN IN THE PUMP. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING HIGH BLOOD GLUCOSE LEVELS UP IN THE 500 + MG/DL RANGE RELATED TO BAD INSULIN. THE PATIENT REPORTED RECEIVING INSULIN VIA THE MAIL AND THE VIALS WERE PACKED IN A BAG WITH ICE. THE PATIENT INDICATED THAT SOME OF THE VIALS SEEMED TO HAVE CHANGED CONCENTRATION RELATED TO WHETHER THE SUPPLIES WERE FROZEN OR NOT. THE PATIENT STATED THAT THE BEING USED AT THE TIME OF THE ELEVATION WAS CHANGED OUT WITH A GOOD VIAL OF INSULIN AND BLOOD GLUCOSE LEVELS RESOLVED TO NORMAL RANGE. THE PATIENT CONFIRMED THAT THERE WAS NO NEED FOR MEDICAL ATTENTION ASSOCIATED WITH THE EVENT. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO THE USE OF BAD INSULIN DURING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225974 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening