BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4242030 · Received November 10, 2014

    Report

    Report Number
    2531779-2014-32112
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 25, 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 DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/06/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT WAS UNABLE TO BE DUPLICATED WITH INVESTIGATION. REVIEW OF THE BLACK BOX REVEALED LOW BATTERY WARNINGS. A BATTERY COMPARTMENT CRACK WAS OBSERVED. THE RETURNED BATTERY CAP THREADS WERE DAMAGED; THE CAP WAS UNABLE TO SECURE PROPERLY TO THE PUMP, HOWEVER, A POWER ISSUE WAS NOT EXPERIENCED. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE WITHOUT ISSUE OR ALARM. THE PUMP¿S ELECTRIC POWER DRAW WAS FOUND TO BE WITHIN SPECIFICATION. THERE WAS NO DAMAGE OR DEFECT TO THE PUMP¿S INTERNAL COMPONENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BATTERY LIFE ISSUE. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722271 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR