BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2974682 · Received February 22, 2013

    Report

    Report Number
    3008382007-2013-03423
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    January 28, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE PATIENT RETURNED TWO ADDITIONAL LOTS OF TEST STRIPS, LOT # 3339367 AND # 3339369, BOTH OF WHICH ALSO PASSED TESTING. DURING PRODUCT ANALYSIS A SECONDARY ISSUE WAS FOUND WITH THESE TWO LOTS; IT WAS DETERMINED THE TEST STRIP VIALS CONTAINED EXTRA STRIPS. THE PATIENT'S RETURNED METER WAS RECEIVED, HOWEVER TESTING HAS NOT YET BEEN PERFORMED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4): THE REPORTED COMPLAINT WAS OBSERVED ON THE ERROR LOG, HOWEVER, NO MESSAGE WAS OBSERVED DURING CONTROL SOLUTION TESTING. PA WAS UNABLE TO REPRODUCE THE COMPLAINT. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(4) 2013 THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ 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
    78557 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3299872

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR