BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3294751 · Received August 19, 2013

    Report

    Report Number
    2531779-2013-13145
    Event Type
    Malfunction
    Date Received
    August 19, 2013
    Report Date
    July 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION AND DEVICE EVALUATION WAS COMPLETED BY PRODUCT ANALYSIS ON 07/23/2013 WITH THE FOLLOWING FINDINGS: BLACK BOX REVIEW SHOWS SEVERAL ¿LOSS OF PRIME¿ DUE ZERO FORCE WARNINGS ON THE REPORTED EVENT DATE. PUMP POWERS ¿ON¿ AND DISPLAYS ¿VERIFY¿ SCREEN. THE PUMP WAS UNABLE TO DETECT THE CARTRIDGE UPON THE FIRST ¿LOAD¿ ATTEMPT. ¿LOAD STEP MALFUNCTION¿ WAS DUPLICATED. UNABLE TO ADEQUATELY INVESTIGATE REPORTED ¿LOSS OF PRIME¿. PUMP¿S COVER WAS REMOVED AND INSPECTION SHOWS MOISTURE CORROSION TO THE PRINTED CIRCUIT BOARD, THE FORCE SENSOR MULTIPLEXER, AND THE FORCE SENSOR PLATE. FORCE SENSOR RESISTANCE MEASUREMENT WAS FOUND ABOVE SPECIFICATION.

    Description of Event or Problem · 1

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED MOISTURE CORROSION ON THE PRINTED CIRCUIT BOARD AND CONFIRMED A LOAD STEP MALFUNCTION. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON 07/23/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400808 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR