BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2851429 · Received November 29, 2012

    Report

    Report Number
    3008382007-2012-06894
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 16, 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 #1 (05/20/2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, ANOTHER FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED LFS ALLEGING INACCURATE READINGS ON THEIR METER COMPARED TO THE LAB. THE PATIENT HAD OBTAINED A 99 MG/DL ON THEIR LFS METER AND L0-30 MINUTES LATER OBTAINED A 80 MG/DL IN THE LAB. THE PATIENT DENIED EXHIBITING ANY SYMPTOMS OR SEEKING ANY MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE. AT THIS TIME 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%.

    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 3343420

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR