BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANIMAS

    MDR report key: 1824591 · Received August 30, 2010

    Report

    Report Number
    MW5017288
    Event Type
    Death
    Date Received
    August 30, 2010
    Date of Event
    August 5, 2007
    Report Date
    August 30, 2010
    Manufacturer
    UNK
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY HUSBAND HAD BEEN GIVEN AN INSULIN PUMP FROM ANIMAS. HE WAS ADVISED THAT HE NOW HAD LIFE WITHOUT LIMITS. (B)(6) TOLD HIM HE COULD SWIM WITH DEVICE ATTACHED. SEVERE INFECTION OCCURRED AND HE BARELY SURVIVED. WAS UNCERTAIN IF HE WOULD LIVE THRU MONTHS OF TREATMENT. WHEN RELEASED FROM (B)(6) HOSPITAL, WAS INFORMED NO MORE FOREIGN OBJECTS ALLOWED SINCE PACEMAKER HAD TO BE REMOVED. (B)(6) HOSPITAL INSTRUCTED HIM TO RESUME INSULIN PUMP. PUMP MALFUNCTIONED, RESETTING TO A DATE OF MORE THAN 1 YEAR PRIOR AND ADMINISTERED MASSIVE DOSE OF INSULIN. HUSBAND LATER DIED. HE BEGAN USING THIS PUMP JUST A FEW MONTHS BEFORE THE STAPH INFECTION OCCURRED DUE TO NURSE FROM (B)(6) TRAINED HIM AND PROMOTED HIM SWIMMING AND BEING ABLE TO EAT AND DO WHATEVER HE WANTED. HER EXACT WORDS DURING 1ST SESSION WERE "WE HERE AT (B)(6) LIKE TO STATE THAT BY USING THE INSULIN PUMP, YOU CAN NOW LIVE WITHOUT LIMITS." DATES OF USE: (B)(6)2007-(B)(6)2007; (B)(6)2007-(B)(6)2007. DIAGNOSIS OR REASON FOR USE: DIABETIC_HIGH BLOOD SUGAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS ANIMAS 20/20 LZG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| H| L| O