BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1973028 · Received January 20, 2011

    Report

    Report Number
    2531779-2011-00362
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Report Date
    December 22, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. THE EVAL OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVAL IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT CONTACTED ANIMAS ALLEGING THE PUMP AND PUMP BATTERY WERE EXTREMELY HOT TO TOUCH. THE PT DENIED THAT SHE WAS BURNED OR INJURED BECAUSE OF THE ALLEGED ISSUES. THE PT ALSO DENIED THAT THE BATTERY WAS LEAKING OR THAT THERE WAS CORROSION IN THE BATTERY COMPARTMENT. NO ASSOCIATED ALARMS WERE OBSERVED IN THE PUMP HISTORY. THE PT WAS INSTRUCTED TO DISCONTINUE USING THE PUMP AND TO IMPLEMENT A BACKUP PLAN. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO ALLEGATION THAT THE PUMP AND PUMP BATTERY FELT HOT TO TOUCH. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUES CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PT DID NOT ALLEGE ANY HARM OR INJURY BECAUSE OF THE ALLEGED ISSUES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1