BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1935498 · Received December 14, 2010

    Report

    Report Number
    2531779-2010-02882
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2010, ALLEGING AN OVERHEATING BATTERY. THE REPORTER CONTACTED ANIMAS ON BEHALF OF HER SON (THE PT). SHE CLAIMED THAT THE PT WOKE UP WITH THE PUMP ALARMING LOW BATTERY. WHEN THE BATTERY WAS REMOVED, THE REPORTER CLAIMED THAT THE BATTERY WAS HOT. SHE DENIED THAT THE PUMP WAS HOT. THE ANIMAS REP INSTRUCTED THE REPORTER TO REMOVE THE PUMP AND FOLLOW A BACKUP PLAN. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED BATTERY ISSUE. THERE IS NO EVIDENCE, HOWEVER, THE PT SUFFERED A SERIOUS INJURY BECAUSE OF THE ALLEGED ISSUE. THE REPORTER DID NOT ALLEGE ANY HARM DUE TO THE REPORTED BATTERY ISSUE.

    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