BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3884404 · Received June 19, 2014

    Report

    Report Number
    2531779-2014-17617
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 08/08/2014. DEVICE EVALUATION: THE METER REMOTE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE METER FOUND SOME COSMETIC DAMAGES. ON INVESTIGATION, THE METER POWERED UP AND DOWNLOADED SUCCESSFULLY. THE REPORTED ERROR MESSAGE WAS OBSERVED IN THE METER DOWNLOAD. THE METER SCREEN AND BUTTONS FUNCTIONED PROPERLY, AND PAIRED WITH A TEST PUMP SUCCESSFULLY. NO ERROR MESSAGES OCCURRED DURING THE EVALUATION. THE REPORTED ERROR MESSAGE WAS VERIFIED IN THE DOWNLOAD BUT NOT DUPLICATED IN THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE METER REMOTE HAS NOT BEEN RETURNED TO ANIMAS. IF THE METER 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 THAT THE METER REMOTE GAVE ERROR 1 MESSAGES AT RANDOM FOR THE PAST 30 DAYS. 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
    362014 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR