BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2862692 · Received December 10, 2012

    Report

    Report Number
    2531779-2012-14305
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 8, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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) 2012, THE REPORTER CONTACTED ANIMAS ALLEGING THE FOLLOWING: THE POWER TO PUMP WOULD SHUT OFF SPONTANEOUSLY , BEGINNING A FEW MONTHS AGO. THIS WOULD OCCUR 1-2 TIMES EVERY 2 MONTHS, BEGINNING IN (B)(6). THE BATTERY CAP WAS NOT CHANGED EVERY 6 MONTHS AS PER THE INSTRUCTIONS FOR USE: IT WAS LAST CHANGED 1 YEAR AGO. THERE WAS REPORTEDLY NO STRUCTURAL DAMAGE TO BATTERY COMPARTMENT OR BATTERY CAP. THERE ARE NO REPORTED BLOOD GLUCOSE EXCURSIONS DUE TO LOSS OF POWER. THE PATIENT IS NO LONGER USING PUMP AND IS ON A BACKUP PLAN, AND DOES NOT HAVE THE PUMP AVAILABLE FOR TROUBLESHOOTING. THIS ISSUE IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP RANDOMLY AND REPEATEDLY LOSES POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR