BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3181979 · Received June 21, 2013

    Report

    Report Number
    3008382007-2013-17980
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    June 5, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH VERIOIQ METER WAS DISPLAYING INACCURATE RESULTS WHEN COMPARED TO THE SAME METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 AT AN UNKNOWN TIME. THE PATIENT REPORTED OBTAINING READINGS OF¿ 110, 180, 199, 230, 244, 318 AND 338 MG/DL¿ ON THE LFS METER IN LESS THAN 20 MINUTES. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF (B)(4). THE PATIENT ALSO MADE COMPARISON OF ¿199 VS. 486, 228 VS. 240 AND 249 VS 214 MG/DL¿ BUT THE TIME DIFFERENCE BETWEEN THE READINGS WAS GREATER THAN 2 HOURS. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANAGE HER DIABETES. THE PATIENT REPORTED TAKING HER USUAL DIABETES MEDICATION ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED 1 WEEK AFTER THE ALLEGED ISSUE FIRST OCCURRED SHE DEVELOPED SYMPTOMS OF ¿DIZZY, BLURRED VISION AND WEAK.¿ THE PATIENT REPORTED ON (B)(6) 2013 THE PATIENT WAS SEEN IN A DOCTOR¿S OFFICE VISIT AND READINGS OF ¿244 AND 200 MG/DL¿ WERE OBTAINED AND THE PATIENT¿S DOCTOR INCREASED HER USUAL DOSE OF MEDICATIONS DUE TO THE READINGS. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT DURING THE TIME OF TESTING AND THE PATIENT WAS USING AN APPROVED SAMPLE SITE TO OBTAIN THE SAMPLES. THE PATIENT REPORTED USING THE CORRECT TESTING STEPS TO OBTAIN THE SAMPLE. THE PATIENT¿S TEST STRIPS AND TEST STRIPS VIAL WERE IN GOOD CONDITION. HOWEVER A CONTROL SOLUTION TEST WAS NOT COMPLETED DUE TO THE PATIENT NOT HAVING ANY CONTROL SOLUTION AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT¿S REPORTED CHANGE IN MEDICATIONS BY HER DOCTOR SUGGESTED THAT THE METER WAS READING ACCURATELY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT PERFORMED A METER VS. THE SAME METER COMPARISON WHERE THE CALCULATED DIFFERENCE OF THE RESULTS MEETS LFS¿ CRITERIA FOR PRECISION REPORTING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281692 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3454050

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR