BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3803099 · Received May 9, 2014

    Report

    Report Number
    2531779-2014-13126
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    ON (B)(6) 2014, THE PATIENT CONTACTED ANIMAS ALLEGING THAT SHE CAME OFF THE PUMP DUE TO A KEYPAD ISSUE AND WHILE ON A BACK-UP PLAN FOR INSULIN DELIVERY, SHE EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) OVER 500MG/DL WITH BLURRED VISION AND DROWSINESS. THE PATIENT DID NOT SPECIFY HOW SHE TREATED THE BG EXCURSION. THE PATIENT STATED THAT ALL KEYPAD BUTTONS WERE OVERLY RESPONSIVE AS WELL AS UNDER-RESPONSIVE AT TIMES, AND THAT THE ISSUE WAS CAUSING UNDER-DELIVERY OF INSULIN. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON A BACK-UP PLAN FOR INSULIN DELIVERY ASSOCIATED WITH A PUMP MALFUNCTION THAT RESULTED IN THE PATIENT COMING OFF THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281324 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening