BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4260437 · Received November 18, 2014

    Report

    Report Number
    2531779-2014-33151
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Report Date
    November 4, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 02/03/2015-PRODUCT ANALYSIS:THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/21/2014 WITH THE FOLLOWING FINDINGS:THE COMPLAINT WAS UNABLE TO BE INVESTIGATED DUE TO AN UNRELATED ISSUE. THE PUMP WAS UNRESPONSIVE. THE PUMP¿S IDLE POWER DRAW WAS OUT OF SPECIFICATION. EVALUATION REVEALED OF AN ELECTRICAL COMPONENT FAILURE; REPLACEMENT OF THE COMPONENT RETURNED THE POWER DRAW TO SPECIFICATION. NO MOISTURE WAS OBSERVED ON THE PUMP¿S COMPONENTS.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) 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
    744541 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR