BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3950106 · Received July 22, 2014

    Report

    Report Number
    2531779-2014-20940
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    July 10, 2014
    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 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 09/10/2014 WITH THE FOLLOWING FINDINGS: THE PUMP BATTERY COMPARTMENT WAS NOTED TO BE CRACKED FROM THE THREADS TO THE CASE SEAL BUT THERE WAS NO NOTED MOISTURE INGRESS INSIDE THE BATTERY COMPARTMENT. THE PUMP WAS NOTED TO HAVE MOISTURE VISIBLE BEHIND THE DISPLAY SCREEN LENS. THE PUMP POWERED ON WITH FUNCTIONING AUDIBLE TONES BUT THE DISPLAY SCREEN REMAINED BLANK AND THERE WAS NO VIBRATION PRESENT. A PUMP LEAK TEST FOUND THAT THE PUMP CASING WAS LEAKING. THE PUMP WAS OPENED AND EVIDENCE OF MOISTURE WAS OBSERVED THROUGHOUT THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP HAD NO POWER. UPON REVIEW, THE REPORTER INDICATED THAT THERE WAS MOISTURE VISIBLE BEHIND THE PUMP DISPLAY SCREEN HOWEVER THERE WAS NO NOTED DAMAGE TO THE PUMP. 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
    428411 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR