BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2933907 · Received January 29, 2013

    Report

    Report Number
    3008382007-2013-01782
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 7, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT RETURNED THE PRODUCTS TO LIFESCAN FOR EVALUATION. THE PATIENT'S RETURNED TEST STRIPS WERE INVESTIGATED BY PRODUCT ANALYSIS WITH FAILING RESULTS, GIVING AN ERROR 4 ERROR MESSAGE DURING TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED METER FAILED TESTING. THE ALLEGED ERROR MESSAGE WAS CONFIRMED IN THE METERS ERROR LOG: HOWEVER, THE ERROR MESSAGE WAS NOT REPRODUCIBLE DURING INVESTIGATIONS. THE CAUSE OF THE REPORTED ERROR MESSAGE IS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO PRO METER WAS GIVING AN UNSPECIFIED ERROR MESSAGE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE. AS THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING THIS COMPLAINT IS BEING REPORTED. 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
    38808 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3347923

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR