BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO2 METER

    MDR report key: 6002369 · Received October 6, 2016

    Report

    Report Number
    3008382007-2016-51707
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Report Date
    September 14, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K131363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS 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.

    Description of Event or Problem · 1

    ON SEPTEMBER 14, 2016, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE ONETOUCH VERIO 2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. IT IS NOT SPECIFIED WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF ¿230, 140, 300 AND 123MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE RESULTS FELL OUTSIDE EXPECTED VALUES FOR PRECISION TESTING. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION BECAUSE OF THE REPORTED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE WAS USED FOR TESTING. THE PATIENT CONFIRMED THE TEST STRIP VIAL WAS CRACKED OR BROKEN; HOWEVER, THERE WAS NO INDICATION OF MISUSE. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY SINCE THE PATIENT DENIED DEVELOPING SYMPTOMS OR RECEIVING MEDICAL TREATMENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED INACCURACY REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655144 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4005817

    Patients

    Seq Age Sex Outcome Treatment
    1