BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4242063 · Received November 10, 2014

    Report

    Report Number
    2531779-2014-32107
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 25, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER REMOTE HAS NOT BEEN RETURNED TO ANIMAS. 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

    DEVICE EVALUATION: THE METER REMOTE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE METER REMOTE WAS POWERED ON AND IMMEDIATELY EMITTED AND ERROR 1 WITH SUB CODE 7. THE METER REMOTE COULD NOT BE PAIRED WITH A TEST PUMP DUE TO THE ERROR. THE ERROR COULD NOT BE CLEARED, INDICATING CORRUPTED DATA.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A METER ERROR (ERROR 1) ISSUE. IT WAS REPORTED THAT THE METER REMOTE EMITTED AN ERROR 1 WITH SUB CODE 7 DURING AN ATTEMPTED BOLUS, AND THE ERROR ALLEGEDLY DID NOT CLEAR. 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
    722814 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR