BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3950403 · Received July 22, 2014

    Report

    Report Number
    2531779-2014-20957
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/25/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX AND PUMP HISTORY WERE UNABLE TO BE DOWNLOADED DUE TO INTERNAL MOISTURE. THE PUMP POWERED ON WITH NO DISPLAY, BUT AUDIO AND VIBRATION WERE PRESENT. THERE WAS VISIBLE MOISTURE IN THE DISPLAY AND THE PUMP FAILED THE LEAK TEST DUE TO A BATTERY COMPARTMENT CRACK. THE PUMP WAS OPENED AND REMOVED FROM THE CASE AND THERE WAS MOISTURE AND CORROSION VISIBLE INTERNALLY.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. IT WAS REPORTED THAT THERE WAS MOISTURE OBSERVED BEHIND THE DISPLAY SCREEN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428331 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR