BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2210728 · Received August 12, 2011

    Report

    Report Number
    2531779-2011-05851
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Report Date
    July 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX HISTORY SHOWED ONE UNEXPLAINED POWER RESET. THE PUMP WAS POWERED ON AND EXERCISED FOR 24 HOURS WITHOUT POWER LOSS. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ALLEGING THAT THE PUMP REPEATEDLY WAS REBOOTING. THE PATIENT CONFIRMED THERE ARE NO CRACKS ON OR IN PUMP AROUND BATTERY COMPARTMENT AND DENIED SEEING ANY MOISTURE OR CORROSION IN THE BATTERY COMPARTMENT. THE PATIENT CONFIRMED THE PUMP'S BATTERY CAP WAS REPLACED JUST A FEW DAYS PRIOR. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR