BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4741373 · Received April 30, 2015

    Report

    Report Number
    2531779-2015-14597
    Event Type
    Injury
    Date Received
    April 30, 2015
    Date of Event
    April 18, 2015
    Report Date
    April 19, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT REQUIRED FOR RETURN TO ANIMAS.

    Description of Event or Problem · 1

    ON (B)(6) 2015 THE REPORTER CONTACTED ANIMAS ALLEGING THE PATIENT¿S BLOOD GLUCOSE ON (B)(6) 2015 WAS BETWEEN 250-499 MG/DL WITH EXTREME THIRST. IT WAS REPORTED THE PATIENT SELF-TREATED WITH INSULIN VIA INJECTION, PUMP THERAPY WAS DISCONTINUED, AND THE PUMP¿S SETTINGS WERE NOT RECENTLY CHANGED. DURING TROUBLESHOOTING, IT WAS REPORTED THAT: THE PUMP¿S BASAL HISTORY AND TOTAL DAILY DOSE BASAL HISTORY WERE APPROPRIATE FOR THE PROGRAMMED BASAL RATES; THE BOLUS HISTORY MATCHED THE TOTAL DAILY DOSE BOLUS HISTORY; THE BOLUS HISTORY RECORDED WAS ACCURATE AS PROGRAMMED; THE PUMP WAS CALCULATING RECOMMENDED BOLUS TOTALS CORRECTLY; THE PUMP SUCCESSFULLY DELIVERED AN AIR BOLUS, WHICH WAS CORRECTLY RECORDED IN THE BOLUS HISTORY. IT WAS DETERMINED THE PATIENT¿S FAILURE TO BOLUS CONTRIBUTED TO THE ALLEGED HYPERGLYCEMIA. IT WAS DETERMINED DURING TROUBLESHOOTING THE BOLUS TYPE PUMP SETTING WAS INCORRECTLY PROGRAMMED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED HYPERGLYCEMIA WAS ATTRIBUTED TO AN ALLEGED PUMP USE ERROR. THERE WAS NO INDICATION OR ALLEGATION OF A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284086 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR