BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO FLEX METER

    MDR report key: 5895749 · Received August 23, 2016

    Report

    Report Number
    3008382007-2016-43456
    Event Type
    Malfunction
    Date Received
    August 23, 2016
    Report Date
    August 8, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K150214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS FAILED TESTING. THE REPORTED ISSUE WAS 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

    THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS WERE FOUND TO HAVE RESULTS ABOVE RANGE WHEN TESTED WITH CONTROL SOLUTION. ADDITIONAL TESTS WERE PERFORMED ON THE TEST STRIP VIAL AND THE DESICCANT TO CHECK THE STRUCTURAL INTEGRITY AND FOR A POSSIBLE MOISTURE ISSUE. THE STRUCTURAL INTEGRITY OF THE TEST STRIP VIAL WAS FOUND TO BE INTACT DURING A GROSS LEAK TEST. THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND TO CONTAIN LEVELS OF MOISTURE THAT REFLECT NORMAL USE. 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)(6) 2016, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH (WITH STRIP LOT # 3933228) COMPARED TO ANOTHER TEST STRIP LOT. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿9.7 MMOL/L¿ WITH THE SUBJECT STRIP LOT AND ¿4.9 MMOL/L¿ ON THE OTHER STRIP LOT, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547932 OT VERIO FLEX METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3933228

    Patients

    Seq Age Sex Outcome Treatment
    1