BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3243926 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11778
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/28/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BACK BOX HISTORY REVEALED TWO REBOOT EVENTS. THERE WAS A CRACK IN THE BATTERY COMPARTMENT, BUT NO EVIDENCE OF MOISTURE DAMAGE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER LOSS OR BATTERY RELATED WARNINGS PUMP CASE WAS REMOVED, NO EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE PUMP. NO EVIDENCE OF INTERMITTENT CONTACT WAS FOUND WITH THE BATTERY CONTACTS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THEIR DEVICE WAS INTERMITTENTLY POWERING OFF AND RESTARTING. 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
    344491 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR