BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3010786 · Received March 19, 2013

    Report

    Report Number
    3008382007-2013-05569
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 21, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LFS PRODUCT HAS NOT BEEN RETURNED TO LIFESCAN FOR EVALUATION. IF THE SUBJECT PRODUCT IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF LIFESCAN OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE. THIS COMPLAINT WAS BASED ON A USA PATIENT. INCIDENT DESCRIPTION CORRECTED TO TAKE OUT (B)(6).

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING INACCURATE RESULTS. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF 407 WITH A LIFESCAN METER AND 189 MG/DL ON ANOTHER METER, PERFORMED WITHIN UNSPECIFIED MINUTES OF EACH OTHER. IN ADDITION, WHEN THE PATIENT COMPARED THE SUBJECT METER AND OTHER METER TO THE DOCTOR'S METER, HE OBTAINED 97 MG/DL ON THE SUBJECT METER AND OTHER METER, AND 99 MG/DL ON THE DOCTOR'S METER. THE PATIENT ALSO CLAIMED THE SUBJECT METER IS OFF BY 150 MG/DL. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN, ALLEGING INACCURATE RESULTS. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF 407 WITH A LIFESCAN METER AND 189 MG/DL ON ANOTHER METER, PERFORMED WITHIN UNSPECIFIED MINUTES OF EACH OTHER. IN ADDITION, WHEN THE PATIENT COMPARED THE SUBJECT METER AND OTHER METER TO THE DOCTOR'S METER, HE OBTAINED 97 MG/DL ON THE SUBJECT METER AND OTHER METER, AND 99 MG/DL ON THE DOCTOR'S METER. THE PATIENT ALSO CLAIMED THE SUBJECT METER IS OFF BY 150 MG/DL. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED INACCURACY 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
    114134 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1