BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3932614 · Received July 14, 2014

    Report

    Report Number
    2531779-2014-19949
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    July 7, 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

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2016 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE SUSPEND HISTORY SHOWS THE PUMP WAS MANUALLY SUSPENDED ON (B)(6) 2014 AND MANUALLY RESUMED AT (B)(6) 2014. THE PUMP POWERS ON NORMALLY; WITH NO ISSUES. PUMP WAS EXERCISED FOR 24HR DURATION PERIOD; NO SELF-SUSPENDING OCCURRED DURING THIS TIME. PUMP WAS ABLE TO BE MANUALLY SUSPENDED AND MANUALLY RESUMED SUCCESSFULLY DURING TESTING. ALL KEYS ON THE KEYPAD WERE FOUND TO BE RESPONSIVE TO USER INPUT. NO HYPERSENSITIVE OR STUCK KEYS WERE OBSERVED. THE SUSPEND FEATURE WAS FOUND TO BE FUNCTIONING PROPERLY DURING TESTING. THE DISPLAY SCREEN HAS A PINKISH CONTRAST. COVER CRACK OBSERVED BETWEEN CORNER OF DISPLAY LENS AND CASE SEAL. BATTERY COMPARTMENT IS CRACKED ON THE SIDE AT THE THREADS AND CRACKED ABOVE AND BELOW THE BUMPER PAD. RETURNED BATTERY CAP HAS STRIPPED THREADS; TEST CAP USED FOR TESTING. 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. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (SUSPEND) ISSUE. 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
    409542 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR