BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4130935 · Received September 30, 2014

    Report

    Report Number
    2531779-2014-27930
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS UNABLE TO MAINTAIN AN ELECTRICAL CONNECTION WITH RETURNED BATTERY CAP DUE TO THE CAP DETACHING AS A RESULT OF THE THREADS ON THE BATTERY CAP BEING DAMAGED. ALL TESTING WAS PERFORMED WITH A TEST BATTERY CAP. TEST BATTERY CAP IS UNABLE TO FULLY TIGHTEN. BATTERY COMPARTMENT CRACKS WERE OBSERVED FROM THE THREAD AREA TO CASE SEAL AND BELOW THE GRIP PAD. A POWER LOSS WAS NOT DUPLICATED WITH THE TEST CAP. BLACK BOX DATES FROM (B)(6) 2014 SHOWED NO UNEXPLAINABLE PUMP REBOOT EVENTS. THE PUMP WAS EXERCISED WITH A TEST CAP FOR 24 HOURS WITH NO REBOOT, LOSS OF POWER OR CALL SERVICE ALARMS DUPLICATED. THERE WAS NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS INSIDE PUMP. THE PUMP POWERED ON TO A DIM AND DISCOLORED DISPLAY SCREEN. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DISCOLORED AND THE BATTERY CAP COULDN¿T ATTACH TO THE BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607983 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR