BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3030598 · Received April 2, 2013

    Report

    Report Number
    2531779-2013-03413
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION WAS PERFORMED AND A CRACKED BATTERY COMPARTMENT WAS OBSERVED. INVESTIGATION REVEALED THAT THE BATTERY CAP IS STRIPPED AND WILL NOT PROPERLY HOLD POWER TO THE PUMP. THE PUMP BOOTS TO VERIFY SCREEN WITH AUDITORY AND VIBRATORY ALARMS. THE DISPLAY SCREEN WAS FOUND TO HAVE A REDDISH TINT TO IT AND THE TEST DISPLAY WAS INSERTED AND THE REDDISH TINT DID NOT TRAVEL TO THE TEST DISPLAY. A REVIEW OF THE BLACK BOX SHOWS SEVERAL REBOOTS OCCURRING PRIOR TO AND ON THE REPORTED EVENT DATE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO LOSS OF POWER OR REBOOTS BEING DUPLICATED. (B)(6). DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON 02/06/2013 WITH THE FOLLOWING FINDINGS. 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

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED, THE BATTERY CAP WAS STRIPPED AND THE DISPLAY SCREEN HAD A REDDISH TINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133640 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR