BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1843772 · Received September 10, 2010

    Report

    Report Number
    2531779-2010-01237
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 14, 2010
    Report Date
    August 14, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. EVALUATION FOUND THAT THE PUMP POWERS UP PROPERLY AND THE POWER CIRCUIT DOES NOT DRAW EXCESSIVE CURRENT. OVERHEATING COULD NOT BE DUPLICATED. UPON EXAMINATION, THE PUMP WAS FOUND TO EXHIBIT AN UNREPORTED VISIBLE BATTERY COMPARTMENT CRACK AND CORROSION IN THE BATTERY COMPARTMENT. THE PUMP USER GUIDE INSTRUCTS THE USER TO INSPECT THE PUMP AND CONFIRM THAT IT IS OPERATING PROPERLY. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE PUMP WAS HOT TO TOUCH. THE PATIENT DENIED ANY BODILY HARM DUE TO THE TEMPERATURE OF THE PUMP.

    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 39 YR