BEUDAMED
    FDA Adverse Event Summary report: N

    OT VERIO IQ METER

    MDR report key: 5629685 · Received May 4, 2016

    Report

    Report Number
    2939301-2016-21625
    Date Received
    May 4, 2016
    Report Date
    April 22, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT THEIR ONETOUCH VERIO IQ METER READ INACCURATELY HIGH COMPARED TO A ONETOUCH ULTRA2 METER AS WELL AS COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT DID NOT STATE WHEN THE INACCURACY ISSUE FIRST OCCURRED BUT PROVIDED THE FOLLOWING RESULTS WHICH WERE OBTAINED USING THE SUBJECT METER: ¿241, 175, 166, 190, 113 AND 194MG/DL¿ RESPECTIVELY. THESE RESULTS WERE COMPARED TO THE FOLLOWING RESULTS OBTAINED FROM THE ONETOUCH ULTRA2 METER WITHIN 30 MINUTES OF ONE ANOTHER: ¿123, 179, 91, 52, 79 AND 87MG/DL¿ RESPECTIVELY. IN ADDITION TO THESE COMPARISONS, THE PATIENT ALSO OBTAINED FURTHER BLOOD GLUCOSE READINGS WITH THE SUBJECT METER WHICH THEY FELT WERE HIGHER THAN THEIR NORMAL RESULTS AND/OR FEELINGS: ¿142, 177, 204, 205, 200, 142 AND 360-ISH MG/DL¿. THE PATIENT MANAGES THEIR DIABETES BY TAKING 10 UNITS OF HUMULIN INSULIN PER DAY AND DENIED MAKING ANY CHANGES TO THEIR NORMAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED PRODUCT ISSUE. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS AS A RESULT OF THE ALLEGED PRODUCT ISSUE, BUT STATED THAT THEY SELF-TREATED BY TAKING AN ADDITIONAL 7 UNITS OF HUMULIN INSULIN AN UNSPECIFIED PERIOD OF TIME AFTER THE ALLEGED PRODUCT ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE CORRECT UNIT OF MEASURE WAS SET ON THE SUBJECT METER. WHEN PERFORMING A CONTROL SOLUTION TEST THE CONTROL SOLUTION RESULT FELL OUT WITH THE ACCEPTABLE RANGE FOR THE TEST STRIP LOT BEING USED. THE PATIENT¿S PRODUCTS WERE REPLACED AND REQUESTED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THE METER ISSUE CAUSED AND/OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR DID THEY RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288173 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3930735

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR