BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3955125 · Received July 24, 2014

    Report

    Report Number
    2531779-2014-21270
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 13, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 08/13/2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH MOISTURE VISIBLE IN THE DISPLAY LENS. THE PUMP DID NOT POWER ON AND THEREFORE HAD NO AUDIO OR VIBRATION. THE PUMP HISTORY AND BLACK BOX DATA WERE UNABLE TO BE DOWNLOADED. THERE WAS NO DAMAGE FOUND TO THE BATTERY CAP AND ITS CONTACT MEASUREMENTS WERE WITHIN SPECIFICATION. THE BATTERY COMPARTMENT WAS CRACKED. THE PUMP FAILED THE LEAK TEST DUE TO THE BATTERY COMPARTMENT LEAK. THE PUMP COVER WAS REMOVED AND INTERNAL MOISTURE WAS OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE WITH 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
    434567 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR