BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 2841892 · Received November 21, 2012

    Report

    Report Number
    3008382007-2012-06576
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. THE 510(K) NUMBER IS K110637.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT HIS ONETOUCH VERIOIQ METER READ INACCURATELY LOW COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE MEDICAL SURVEILLANCE SPECIALIST WAS UNABLE TO REACH THE PATIENT BY PHONE TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THE ALLEGED METER ISSUE BEGAN ON (B)(6) 2012 AT 8 PM. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF "108 MG/DL" WITH THE SUBJECT METER AND "144 MG/DL" ON ANOTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THESE GLUCOSE READINGS DOES NOT EXCEED THE EXPECTED VALUE OF LESS THAN OR EQUAL TO (B)(4). THE PATIENT INFORMED THE CCA THAT HE MANAGES HIS DIABETES WITH INSULIN. IT IS NOT KNOWN IF THE PATIENT MADE ANY ADJUSTMENTS TO HIS USUAL DIABETES MANAGEMENT IN RESPONSE TO THE ALLEGED LOW READING(S). THE PATIENT INFORMED THE CCA THAT HE DEVELOPED BLURRED VISION; HOWEVER, WAS UNABLE TO CONFIRM IF THE SYMPTOM DEVELOPED PRIOR TO OR AFTER HE OBTAINED THE ALLEGED INACCURATE RESULT(S) WITH THE SUBJECT METER. THE PATIENT REPORTED THAT ON THE MORNING OF (B)(6) 2012, HE SAW HIS HCP AND STATED HE WAS TREATED WITH INSULIN. AT THE TIME OF INITIAL TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS REPORTEDLY TREATED BY AN HCP FOR HYPERGLYCEMIA AFTER THE SUBJECT METER READ INACCURATELY LOW.

    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 3237673

    Patients

    Seq Age Sex Outcome Treatment
    1