BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4242028 · Received November 10, 2014

    Report

    Report Number
    2531779-2014-32103
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 24, 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

    PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/10/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT WAS UNABLE TO BE DUPLICATED WITH INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX REVEALED A REBOOTING EVENT. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. NO DAMAGE OR DEFECT WAS FOUND TO THE PUMP¿S INTERNAL COMPONENTS. UNRELATED TO THE COMPLAINT, A BATTERY COMPARTMENT CRACK WAS OBSERVED. THE RETURNED BATTERY CAP WAS ABLE TO SECURE PROPERLY TO THE PUMP. THE KEYPAD WAS FOUND TO BE TORN. EVALUATION REVEALED ALL KEYPAD BUTTONS WERE APPROPRIATELY RESPONSIVE. THERE WAS NO EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER THE KEY CONTACTS.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER-INTERMITTENT (DAMAGE-BATTERY COMPARTMENT) 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
    722762 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR