BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2993590 · Received March 7, 2013

    Report

    Report Number
    2531779-2013-02489
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION REVEALED THAT THE PRIME HISTORY HAS SEVERAL LARGE PRIMES RECORDED. PERFORMED PUMP REWIND, LOAD, AND PRIME WITH NO LOSS OF PRIME. A LOAD STEP WAS RAN WITH A CARTRIDGE SET TO 100 UNITS AND AFTER LOAD THE PUMP DISPLAYED 100 UNITS. FORCE SENSOR CALIBRATION WAS OUT OF SPECIFICATIONS. THE FORCE SENSOR WAS REMOVED FROM MOTOR ASSEMBLY AND THE FORCE SENSOR PLATE WAS FOUND TO BE CONTAMINATED WITH A GREEN SUBSTANCE. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE KEYPAD SYMBOLS WERE FADED, WHICH HAS NO EFFECT ON INSULIN DELIVERY. THE FORCE SENSOR PLATE RESISTANCE READING OUT OF SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE FORCE SENSOR PLATE WAS CONTAMINATED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97003 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR