BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 2161751 · Received February 17, 2011

    Report

    Report Number
    2531779-2011-00895
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE THE RESULTS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT HE WAS AWAKENED WHEN HIS PUMP FELT HOT TO THE TOUCH. HE REPORTED THAT THE PUMP WAS NOT HOT ENOUGH TO BURN HIM BUT THAT IT WAS HOT ENOUGH TO WAKE HIM UP. HE REPORTED THAT THE BATTERY INDICATOR BARS WERE DECREASING AT THE TIME AND THAT THE PUMP WAS ONLY HOT AT THE BATTERY COMPARTMENT. HE ALSO REMOVED THE BATTERY AND NOTICED THAT THE BATTERY ITSELF WAS HOT. THE HOT BATTERY ALSO DID NOT BURN THE PATIENT.

    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 50 YR