BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3952783 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21020
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 14, 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. 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

    THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/06/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED WITH INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX REVEALED AN UNEXPLAINED REBOOTING EVENT. A BATTERY COMPARTMENT CRACK WAS OBSERVED. THE BATTERY CAP WAS UNABLE TO BE PROPERLY SECURED TO THE PUMP; A POWER LOSS WAS NOT EXPERIENCED DURING INVESTIGATION. MOISTURE WAS OBSERVED WITHIN THE BATTERY COMPARTMENT AND ON THE UNDERSIDE OF THE BATTERY CAP. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. MOISTURE ON THE PUMP¿S INTERNAL COMPONENTS WAS OBSERVED. UNRELATED TO THE COMPLAINT, THE DISPLAY WAS OBSERVED TO BE DIM AND DISCOLORED. THE KEYPAD COVER WAS FOUND TO BE PEELING. ALL KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONSIVE. CONTAMINATION WAS OBSERVED ON ALL KEYPAD BUTTON CONTACTS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) 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
    432136 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR