BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1935499 · Received December 14, 2010

    Report

    Report Number
    2531779-2010-02884
    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
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. THE BATTERY WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. THE COMPLAINT REGARDING THE PUMP OVERHEATING COULD NOT BE DUPLICATED DURING INVESTIGATION. NO ACTIVITY RELATED TO THE COMPLAINT WAS OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. THE PUMP POWERED ON NORMALLY AND WAS EXERCISED FOR 5 HOURS WITH NO OVERHEATING OR ALARMS. THE PUMP ELECTRICAL CURRENT DRAWN WERE TESTED AND FOUND TO BE WITHIN SPEC. NO LEAKS WERE FOUND DURING LEAK TESTING. THE PUMP POWER WAS REMOVED TO INSPECT FOR INTERNAL MOISTURE INGRESS AND NONE WAS FOUND. THE POWER FLEX, BATTERY CONNECTIONS AND INTERNAL COMPONENTS WERE TESTED FOR INTERMITTING CONDITIONS AND NO DEFECTS WERE FOUND.

    Description of Event or Problem · 1

    THE PT CONTACTED ANIMAS ON (B)(6), 2010, ALLEGING THAT THE PUMP AND BATTERY WERE EXTREMELY HOT TO TOUCH. THE PT DENIED BEING BURNED OR HAVING ANY SIGNS OF REDNESS. THE PT DENIED THAT THERE WAS ANY BATTERY CORROSION OR WATER EXPOSURE. THE PT ALSO DENIED ANY SIGNS OF DAMAGE ON THE CAP OR IN THE COMPARTMENT. THE ANIMAS REP CONFIRMED THAT THE PT HAD A BACKUP PLAN. BASED ON THE INFO PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED OVERHEATING PUMP AND BATTERY ISSUE. THERE IS NO EVIDENCE, HOWEVER, THAT THE PT SUFFERED A SERIOUS INJURY BECAUSE OF THE ALLEGED ISSUE. THE REPORTER DID NOT ALLEGE ANY HARM DUE TO THE REPORTED PUMP AND 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