BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3983509 · Received August 6, 2014

    Report

    Report Number
    2531779-2014-22558
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 POWER COMPLAINT COULD NOT BE DUPLICATED. A REVIEW OF THE PUMP¿S BLACK BOX DATA REVEALED A PUMP REBOOT WHEN THE CARTRIDGE WAS CHANGED. A BATTERY CAP WAS NOT RETURNED WITH THE PUMP, AND A TEST CAP WAS USED TO COMPLETE THE INVESTIGATION. THE TEST CAP WAS ABLE TO FULLY SECURE ONTO THE PUMP. THERE WAS NO VISIBLE DAMAGE OBSERVED TO THE BATTERY COMPARTMENT. THERE WAS VISIBLE EVIDENCE OF MOISTURE INSIDE THE BATTERY COMPARTMENT. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS OR DUPLICATED ALARMS. THE LEAK TEST PASSED. THE PUMP WAS OPENED AND MOISTURE WAS OBSERVED ON INTERNAL COMPONENTS OF 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 THERE WAS EVIDENCE OF MOISTURE IN THE BATTERY COMPARTMENT. 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
    460112 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR