BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3112228 · Received May 14, 2013

    Report

    Report Number
    2531779-2013-06385
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: AN OCCLUSION ALARM 145 WAS VERIFIED IN THE ALARM HISTORY ONLY. INVESTIGATORS PERFORMED PUMP REWIND, LOAD, AND PRIME WITH NO OCCLUSIONS. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL PROGRAM WITH NO OCCLUSIONS. INVESTIGATORS WERE UNABLE TO DUPLICATE ANY OCCLUSION ALARMS. THE FORCE CALIBRATION WAS NOT IN SPECIFICATIONS. DISASSEMBLED FORCE SENSOR PLATE. FORCE SENSOR RESISTANCE READING WAS IN SPECIFICATIONS AND THE BAD FORCE SENSOR CALIBRATION. WHEN THE CASE WAS REMOVED FROM THE AS IT WAS BEING OPENED THE DISPLAY WAS LOSS. THE GRAY TAPE ON THE BACK OF THE DISPLAY WAS PRESENT BUT DID NOT HOLD THE DISPLAY DOWN ONTO THE PUMP. (B)(6). DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 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 FORCE SENSOR CALIBRATION WAS NOT IN SPECIFICATIONS. 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
    212357 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR