BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3580775 · Received January 17, 2014

    Report

    Report Number
    2531779-2014-01833
    Event Type
    Malfunction
    Date Received
    January 17, 2014
    Report Date
    December 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/23/2013 WITH THE FOLLOWING FINDINGS: THE BLACK BOX REVIEW SHOWS TWO ¿CS088¿ WATCHDOG ALARMS ON THE REPORTED EVENT PERIOD. THE PUMP POWERS ON AND DISPLAYS VERIFY SCREEN. THE PUMP WAS PRIMED CORRECTLY, ¿CS088¿ ALARM OCCURRED DURING THE 24 HOUR DURATION TEST WITH CONSISTENT BUZZING SOUND. THE PUMP¿S COVER WAS REMOVED; INSPECTION SHOWS AN INTERMITTENT CONDITION TO THE PCB ILLUSTRATED WITH AN OPEN TRACE BETWEEN THE ¿U38-WATCHDOG CHIP¿ AND THE¿ MASTER MICROPROCESSOR. (B)(4).

    Description of Event or Problem · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/23/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT AN INTERMITTENT CONDITION TO THE PCB ILLUSTRATED WITH AN OPEN TRACE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44323 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR