BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1954392 · Received December 14, 2010

    Report

    Report Number
    2531779-2010-02844
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 13, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVAL. EXAMINATION REVEALED NO PHYSICAL DAMAGE OR EVIDENCE OF MOISTURE INGRESS TO THE BATTERY COMPARTMENT; THE BATTERY CAP WAS FOUND TO BE INTACT AND ABLE TO BE SECURED WITHOUT DIFFICULTY. EVAL FOUND THAT PUMP POWERED UP PROPERLY AND THE POWER CIRCUIT DID NOT DRAW EXCESSIVE CURRENT. THE PUMP WAS EXERCISED FOR THREE HOURS AND NO OVERHEATING OR ALARMS WERE DUPLICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP AND BATTERY BECAME HOT TO TOUCH. THE PT DENIED THE NEED FOR MEDICAL TREATMENT BECAUSE OF THE TEMP OF THE PUMP. HE STATED THAT THE BATTERY COMPARTMENT IS INTACT, THE BATTERY CAP IS SECURE AND IS TIGHTENED WITH A COIN, AND THERE IS NO CORROSION IN THE BATTERY COMPARTMENT. THE PT STATED THAT HE REPLACED THE BATTERY AND HAS HAD NO FURTHER SIGNS OF OVERHEATING.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR