BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRASMART METER

    MDR report key: 2990487 · Received March 5, 2013

    Report

    Report Number
    3008382007-2013-04266
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 12, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K021819
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE PATIENT ALLEGED THE METER DISPLAY WAS FREEZING ON THE CALIBRATION CODE NUMBER, HOWEVER THIS COMPLAINT WAS NOT CONFIRMED. A SECONDARY ISSUE WAS DISCOVERED IN THAT THE BATTERY CONTACTS WERE CORRODED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE PATIENT ALLEGED THE METER DISPLAY WAS FREEZING ON THE CALIBRATION CODE NUMBER, HOWEVER, THIS COMPLAINT WAS NOT CONFIRMED. A SECONDARY ISSUE WAS DISCOVERED IN THAT THE BATTERY CONTACTS WERE CORRODED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93055 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 1024621

    Patients

    Seq Age Sex Outcome Treatment
    1