BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3912690 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-19055
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS RETURNED WITH VISIBLE EVIDENCE OF MOISTURE BEHIND THE DISPLAY LENS. DURING TESTING, THE PUMP COULD NOT POWER ON AND THERE WERE NO FUNCTIONING AUDITORY AND VIBRATORY SETTINGS. THE BATTERY COMPARTMENT WAS CRACKED. THE LEAK TEST FAILED DUE TO A BATTERY COMPARTMENT AND AUDIO BOLUS BUTTON LEAK. THE PUMP WAS OPENED AND EVIDENCE OF MOISTURE CONTAMINATION WAS OBSERVED INSIDE THE PUMP.

    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 A POWER (MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED THAT THE PUMP HAD NO POWER. IT WAS NOTED THAT THERE WAS MOISTURE/CORROSION BEHIND THE DISPLAY. 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
    389143 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR