BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2852418 · Received November 30, 2012

    Report

    Report Number
    3008382007-2012-06966
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Report Date
    November 17, 2012
    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

    FOLLOW-UP # 2 ¿ (6/19/2013).THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/172013 AND 5/25/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE TEST STRIP HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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

    THE PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2012 ALLEGING INACCURATE READINGS ON HIS METER. THE PATIENT HAD OBTAINED A 29 MG/DL AND THEN A MINUTE LATER RETESTED AND OBTAINED A 107 MG/DL A MINUTE LATER ON (B)(6) 2012. THE PATIENT DENIED EXHIBITING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. THE PATIENT ALSO DENIED RECEIVING ANY TREATMENT OR CONTACTING THEIR PHYSICIAN DUE TO THE ALLEGED ISSUE. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE COMPLAINT IS BEING REPORTED SINCE THE RESULT IS GREATER THAN 20% OR MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3318776

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR