BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3900583 · Received June 27, 2014

    Report

    Report Number
    2531779-2014-18579
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    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 AN ERROR 1 WITH SUB CODE 5 (RECORD RAM LIST CANNOT BE SETUP). THE ERROR COULD NOT BE CLEARED, AND THE METER REMOTE DID NOT PAIR WITH A PUMP TO COMPLETE INVESTIGATION, INDICATING SOFTWARE DATA CORRUPTION.

    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.

    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 5 AT RANDOM THAT COULD NOT BE CLEARED. 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
    378130 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR