BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 5900309 · Received August 24, 2016

    Report

    Report Number
    3008382007-2016-43686
    Event Type
    Injury
    Date Received
    August 24, 2016
    Report Date
    August 21, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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.

    Description of Event or Problem · 1

    ON (B)(6) 2016 THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THEIR ONETOUCH VERIOIQ METER WAS READING INACCURATELY ERRATIC. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT ALLEGED THAT THE PRODUCT ISSUE BEGAN ON THE MORNING OF (B)(6). THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF 177, 160, 140 AND 180MG/DL ON THE SUBJECT METER, OBTAINED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY THESE READINGS MEET LIFESCAN'S CRITERIA FOR PRECISION. THE PATIENT MANAGES THEIR DIABETES WITH PILLS, DIET AND EXERCISE. THE PATIENT DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED DEVELOPING A SYMPTOM OF "FREQUENT URINATION" ON (B)(6). THE PATIENT DENIED RECEIVING ANY TREATMENT FOR THIS SYMPTOM. AT THE TIME OF TROUBLESHOOTING THE CCA VERIFIED THAT THE TEST STRIPS WERE STORED CORRECTLY (PER OWNER'S BOOKLET RECOMMENDATION). THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED A SERIOUS SYMPTOM OF HYPERGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551982 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3891413

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening