BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1983260 · Received February 2, 2011

    Report

    Report Number
    2531779-2011-00646
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVAL REVEALED EVIDENCE OF MOISTURE INGRESS ON THE PCB COMPONENTS. VISUAL INSPECTION DID NOT REVEAL ANY PUMP DEFECT. REVIEW OF THE PUMP DOWNLOAD HISTORY VERIFIED ONE POWER ON RESET EVENT AFTER A REWIND COMMAND. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ANY POWER LOSS OR REBOOTING DUPLICATED.

    Description of Event or Problem · 1

    THE REPORTER ALLEGED THAT THE PUMP KEPT SHOWING THE VERIFY SCREEN AND REBOOTED WITHOUT USER INTERVENTION. SHE DENIED THAT THE PUMP HAD ANY CRACKS OR DAMAGE TO THE BATTERY COMPARTMENT AND THE BATTERY CAP WAS SECURED PROPERLY WITH A COIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORP. ONE TOUCH PING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR