BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1924661 · Received December 10, 2010

    Report

    Report Number
    2531779-2010-02800
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS WITHOUT THE COMPLAINANT BATTERY. THE BATTERY COMPARTMENT AND CAP WERE FOUND TO BE INTACT WITH NO EVIDENCE OF MOISTURE INGRESS. EVAL FOUND THAT THE PUMP POWERS UP PROPERLY WITH A TEST BATTERY. THE PUMP WAS EXERCISED FOR 3 HOURS WITH NO EVIDENCE OF OVERHEATING OR ALARMS. HIGH CURRENT DRAWS WERE FOUND DURING TESTING, A CAPACITOR IN THE PIEZO CIRCUIT WAS FOUND TO HAVE FAILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FAMILY MEMBER NOTICED THAT THE BATTERY WAS HOT WHEN SHE REMOVED IT FROM THE PUMP DURING A ROUTINE BATTERY CHANGE. SHE STATED THAT IT WAS NOT HOT ENOUGH TO BURN THE PT. THE FAMILY MEMBER SAID THAT SHE INSPECTED THE BATTERY COMPARTMENT, SHE DENIED MOISTURE OR CORROSION IN COMPARTMENT, AND SHE STATED THAT THE BATTERY DID LOOK CORRODED.

    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 12 YR