BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2963744 · Received February 15, 2013

    Report

    Report Number
    3008382007-2013-03085
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    February 1, 2013
    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
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER WAS EVALUATED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. PA WAS UNABLE TO REPRODUCE THE COMPLAINT. THE TEST STRIPS PASSED TESTING WITH NO FAULTS FOUND.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) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH VERIOIQ METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT ON THE MORNING OF (B)(6) 2013 SHE OBTAINED BLOOD GLUCOSE READINGS OF "10.5 MMOL/L" WITH THE SUBJECT METER AND "7.6 MMOL/L" ON A LABORATORY DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF (B)(4). DURING THE FOLLOW-UP CALL, THE PATIENT CONFIRMED THAT PRIOR TO THE METER TO LAB COMPARISON, THERE WERE NO READINGS OBTAINED WITH THE SUBJECT METER THAT SHE FELT WERE HIGHER THAN EXPECTED. AFTER SEEING THE DISCREPANCY BETWEEN THE METER READING AND LAB RESULT, THE PATIENT WAS CONCERNED THAT SHE WOULD NOT BE ABLE TO DETECT WHEN HER BLOOD SUGAR WAS DROPPING. THE PATIENT MENTIONED SHE WAS ASYMPTOMATIC AND DEPENDED ON THE METER TO LET HER KNOW WHEN SHE WAS GOING LOW. AT THE TIME OF THE FOLLOW-UP CALL, THE PATIENT DENIED DEVELOPING SYMPTOMS OR RECEIVING MEDICAL INTERVENTION FOR A LOW BLOOD GLUCOSE EXCURSION. THE PATIENT INFORMED THE CSR THAT ON(B)(6) 2013 SHE TESTED SEVERAL TIMES THROUGHOUT THE DAY WITH ANOTHER DEVICE (ONETOUCH ULTRA2) UNTIL SHE RAN OUT OF TEST STRIPS. ON (B)(6) 2013, THE PATIENT OBTAINED READINGS THAT RANGED FROM "7.6 TO 15.2 MMOL/L". ON (B)(6) 2013 THE PATIENT OBTAINED BLOOD GLUCOSE READINGS ON THE OTHER DEVICE THAT RANGED FROM "3.8 TO 18.1 MMOL/L". THE PATIENT MENTIONED SHE IS ON AN INSULIN PUMP AND TAKES CORRECTION BOLUSES BASED ON HER CARBOHYDRATE INTAKE AND BLOOD GLUCOSE RESULTS. AT THE TIME OF TROUBLESHOOTING, THE PATIENT CONFIRMED THAT THE TEST STRIPS APPEARED IN GOOD CONDITION, WERE NOT EXPIRED OR OPENED PAST THEIR DISCARD DATE. THE CSR ALSO NOTED THAT THE PATIENT WAS USING THE CORRECT TECHNIQUE TO APPLY THE BLOOD TO THE TEST STRIP. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED AND/OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S REPORTED BLOOD GLUCOSE READINGS OBTAINED ON ANOTHER DEVICE DO NOT MEET LFS CRITERIA OF A SERIOUS INJURY. IN ADDITION, THE PATIENT DENIED RECEIVING MEDICAL TREATMENT FOR A LOW BLOOD GLUCOSE EXCURSION. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS ACCURACY CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68578 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR