BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2050623 · Received March 15, 2011

    Report

    Report Number
    2531779-2011-01595
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. THE EVAL OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVAL IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT CONTACTED ANIMAS ALLEGING THAT A PUMP HAD A CRACKED BATTERY COMPARTMENT. THE PT INDICATED THAT HE NOTICED THE CRACKED CASING THE NIGHT BEFORE CONTACTING ANIMAS. THE PT ALSO CLAIMED THAT HE HAD TO HOLD THE CAP DOWN TO GAIN POWER ON THE PUMP AND TO TAKE A BOLUS EVERY HOUR. ON THE MORNING OF (B)(6) 2011, THE PT CLAIMED THAT HIS BLOOD GLUCOSE (BG) LEVEL WAS 400 MG/DL. AT THAT TIME, THE PT CLAIMED THAT HE HAD A SYMPTOM OF SHORTNESS OF BREATH. THE PT REPORTEDLY TOOK A CORRECTION WITH THE PUMP BY HOLDING THE CAP DOWN AND TAKING A BOLUS. WHILE SPEAKING TO THE ANIMAS REP, HIS BG LEVEL WAS 203 MG/DL. THE PT WAS INSTRUCTED BY THE ANIMAS REP TO A BACKUP PLAN FOR INSULIN DELIVERY. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT HE DEVELOPED A SYMPTOM THAT CAN BE ASSOCIATED WITH A SERIOUS INJURY AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR 1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening