BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3811470 · Received May 15, 2014

    Report

    Report Number
    2531779-2014-13632
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS AS FOLLOWS: CALL SERVICE ALARMS WERE VERIFIED IN THE BLACK BOX AND HISTORY. A CALL SERVICE ALARM OCCURRED DURING THE REWIND STEP FOR WHICH PRODUCT ANALYSIS WAS UNABLE TO COMPLETE FAILED STEPS DUE TO THE ALARM. THE PUMP WAS OPENED AND REMOVED FROM THE CASE AND CORROSION WAS OBSERVED UNDER THE MOTOR FLEX CONNECTOR AND SURROUNDING COMPONENTS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 078) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292039 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR