BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3801467 · Received May 8, 2014

    Report

    Report Number
    2531779-2014-13053
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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.

    Description of Event or Problem · 1

    (B)(6): ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING AN INTERMITTENT POWER ISSUE AND EVIDENCE OF A BATTERY COMPARTMENT CRACK. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THIS MALFUNCTION IS GENERALLY OBVIOUS AND DETECTABLE BY THE USER. IN ADDITION, THE OWNER¿S BOOKLET INSTRUCTS THE USER TO CAL THEIR HEALTHCARE TEAM OR ANIMAS WHEN THEY HAVE A QUESTION OR CANNOT UNDERSTAND AN ISSUE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277406 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR