BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    MDR report key: 1894838 · Received November 5, 2010

    Report

    Report Number
    2531779-2010-02131
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Removal / Correction Number
    2531779-03/24/2010-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO ANIMAS. EVALUATION REVEALED THAT THE FORCE SENSOR RESISTANCE READING WAS OUT OF CALIBRATION. IN ADDITION, VISIBLE MOISTURE INGRESS WAS OBSERVED WITHIN ON THE AREA HOUSING THE FORCE SENSOR. AN EZPRIME OPERATION WAS PERFORMED AND THE PUMP DISPENSED ALL THE INSULIN FROM THE CARTRIDGE DURING THE LOAD STEP AND EMITTED A "NO CARTRIDGE DETECTED" WARNING. THERE WAS ONE "NO CARTRIDGE DETECTED" WARNING IN THE PUMP HISTORY. A MISALIGNED DISPLAY SCREEN WAS ALSO OBSERVED, BUT DID NOT CAUSE THE FORCE SENSOR PINS TO DISLODGE.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE PUMP DISPENSES INSULIN FROM THE CARTRIDGE DURING THE LOAD STEP. THE PT CONFIRMED HIS BODY WAS NOT CONNECTED TO THE PUMP DURING PRIMING STEPS. THERE WAS NO REPORTED PT IMPACT.

    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 31 YR