BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4120281 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27556
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 12/03/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/15/2014 WITH THE FOLLOWING FINDINGS: DUE TO THE DAMAGED DISPLAY SCREEN, PUMP POWERED ON WITH A BLANK DISPLAY. WITHIN THREE MINUTES THE PUMP ALARMED WITH AN AUDIBLE TONE AND VIBRATION ALERT PER NORMAL OPERATION. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN AND MEASURED WITHIN SPECIFICATIONS. THERE WAS A BATTERY COMPARTMENT CRACK OBSERVED BELOW THE GRIP PAD. PUMP REBOOT EVENTS WERE OBSERVED IN THE PUMP'S BLACK BOX ON 9/15/2014. INVESTIGATION COULD NOT BE COMPLETED DUE TO THE PUMP NOT BEING ABLE TO COMPLETE A 24 HOUR DURATION TEST. THE DISPLAY SCREEN WAS CRACKED IN MULTIPLE PLACES.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THERE WAS AN INTERMITTENT POWER 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
    601853 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR