BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS

    MDR report key: 3242765 · Received July 18, 2013

    Report

    Report Number
    MW5030968
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 4, 2013
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I WOKE UP, DID A BG, ATE BREAKFAST. THEN I WALKED INTO THE BEDROOM. I FELL. ACCORDING TO THOSE THERE, I WAS UNABLE TO GET UP AND WAS MUMBLING. EMS WAS CALLED. MY BG WAS OVER 500 (HAS BEEN 140 THE NIGHT BEFORE). I WAS HAVING CARDIAC ARRHYTHMIAS. AT THE HOSPITAL, MY BG WAS UP TO 1040. SOMETIME IN HERE, I HAD A SEIZURE AND WENT INTO RENAL FAILURE. I CONTINUED TO HAVE ARRHYTHMIAS AND ALL OF THIS IS CONSIDERED TO BE DUE TO PUMP FAILURE (INSULIN PUMP). PUMP MANUFACTURE DATE: 06/2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335439 ANIMAS ONE TOUCH PING INSULIN PUMP LZG JOHNSON & JOHNSON ANIMAS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L ANIMAS INSULIN PUMP| QUETIAPINE 25MG 1-2 AT BEDTIME| BUSPAR 30MG BID| LAMICTAL 150MG BID| OMEPRAZOLE/SODIUM BICARBONATE040MG QD| LIOTHYRONINE SODIUM 5 MCG QD| LEVOTHYROXINE 100 MCG QD| CRESTOR 5MG M, W, F| SUPER B BID