BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2193147 · Received August 5, 2011

    Report

    Report Number
    2531779-2011-05639
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED IN A CONDITION THAT IT WOULD NOT POWER ON. THE BATTERY COMPARTMENT AND CAP THREADS WERE FOUND TO BE STRIPPED AND CORROSION WAS FOUND IN THE BATTERY COMPARTMENT. A LEAK TEST WAS PERFORMED AND NO LEAKS WERE FOUND. THE PUMP WAS OPENED AND CORROSION WAS FOUND ON THE BOTTOM OF THE BATTERY CASE AND THE VIBRATION MOTOR. PERFORMANCE TESTING AND BLACK BOX DOWNLOAD WERE UNABLE TO BE OBTAINED DUE TO THE PUMP NOT POWERING.

    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

    THE PATIENT CONTACTED ANIMAS ALLEGING THE PUMP WOULD NOT POWER ON. AT THE TIME OF TROUBLESHOOTING, THE PATIENT CONFIRMED THERE WAS NO STRUCTURAL DAMAGE VISIBLE EITHER ON THE BATTERY CAP OR BATTERY COMPARTMENT. THE PATIENT ALSO CONFIRMED THERE WAS NO CORROSION IN THE BATTERY COMPARTMENT. THE ALLEGED ISSUE REMAINED UNRESOLVED EVEN AFTER THE BATTERY WAS REPLACED. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    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 38 YR