BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3151254 · Received June 7, 2013

    Report

    Report Number
    3008382007-2013-15685
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    May 20, 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
    CA
    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) IN (B)(4) ALLEGING HIS ONETOUCH VERIOIQ METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS WELL AS FROM A FOLLOW UP CALL WITH THE PATIENT ON (B)(6) 2013. THE PATIENT REPORTED PRIOR TO THE START OF THE ALLEGED ISSUE ON AN UNKNOWN DATE AND TIME THE PATIENT HAD A READING OF ¿17MMOL/L¿ ON THE LFS METER. THE PATIENT REPORTED HE NORMALLY TAKES METFORMIN 4 TIMES A DAY AND HE TESTS HIS BLOOD GLUCOSE 4-6 TIMES A DAY. THE PATIENT REPORTED HIS USUAL READINGS RANGE FROM ¿5.5-8.0MMOL/L¿ IN RESPONSE TO THE ALLEGED READING, THE PATIENT INCREASED HIS METFORMIN TO 500MG AND DID NOT DEVELOP ANY SYMPTOMS. THE PATIENT REPORTED BETWEEN (B)(6) 2013 HE OBTAINED A READING OF ¿13MMOL/L¿ COMPARED TO ¿9.0 MMOL/L¿ ON AN ACCU-CHEK COMPACT METER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% OR <=4.44MMOL/L WHEN OBTAINED WITHIN 30 MINUTES. THE PATIENT REPORTED IN RESPONSE TO THE ALLEGED READING, HE TOOK HIS MEDICATION AS USUAL. THE PATIENT REPORTED HE DID NOT DEVELOP ANY SYMPTOMS HOWEVER HE WENT TO THE EMERGENCY ROOM AS A PRECAUTION DURING (B)(6) 2012. THE PATIENT REPORTED UPON ARRIVAL HIS BLOOD GLUCOSE WAS TESTED TO BE ¿17MMOL/L¿ AND HE WAS GIVEN METFORMIN, 2 PILLS, JANUVIA 2 PILLS AND IV SALINE WITH MORPHINE FOR HIS BACK PAIN. THE PATIENT REPORTED UPON DEPARTURE HIS BLOOD GLUCOSE READINGS WERE ¿NORMAL.¿ AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT. THE CCA NOTED THE PATIENT WAS USING AN APPROVED SAMPLE SITE TO OBTAIN THE SAMPLES. THE PATIENT WAS FOUND TO BE USING THE CORRECT TESTING STEPS. THE PATIENT¿S TEST STRIPS AND TEST STRIPS VIAL WERE IN GOOD CONDITION. HOWEVER, A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING ANY CONTROL SOLUTION AT THE TIME OF THE CALL. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT¿S REPORTED TREATMENT FROM A HEALTHCARE PROFESSIONAL CORRELATED WITH THE ALLEGED HIGH READING. HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT PERFORMED A METER VS. METER COMPARISON WHERE THE CALCULATED DIFFERENCE OF THE RESULTS MEETS LFS¿ CRITERIA FOR ACCURACY REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252829 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR