BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2832398 · Received November 14, 2012

    Report

    Report Number
    2939301-2012-13138
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 31, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH VERIOIQ METER WAS READING INACCURATELY COMPARED TO THE SAME METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2012, THE PATIENT REPORTED THE ALLEGED ISSUE FIRST BEGAN. ON (B)(6) 2012, THE PATIENT ALLEGED OBTAINING READINGS OF "301MG/DL" AT 4:44AM AND "208MG/DL" AT 4:47AM. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE READINGS EXCEEDS THE EXPECTED RESULT OF <=20% OR <=15MG/DL OBTAINED WITHIN 20 MINUTES OF EACH OTHER. ON (B)(6) 2012, THE PATIENT ALLEGED OBTAINING READINGS OF "263MG/DL" AT 1:53PM AND "117MG/DL" AT 1:58PM, ON THE LFS METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE READINGS EXCEEDS THE EXPECTED RESULT OF <=20% OR <=15MG/DL OBTAINED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT REPORTED USING A COMBINATION OF MEDICATIONS INCLUDING METFORMIN, LANTUS AND JANUVIA (UNKNOWN DOSES) TO MANAGE HIS DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED A FEW WEEKS LATER, HE FELT "TIRED." THE PATIENT REPORTED ON (B)(6) 2012, AT 2:45PM, HE WAS SEEN BY A HEALTHCARE PROFESSIONAL FOR A BLOOD GLUCOSE TEST ONLY. A HBA1C READING OF "9.1%" WAS REPORTEDLY OBTAINED ON A LAB DRAW. THE PATIENT DID NOT REPORT ANY ADDITIONAL MEDICAL INTERVENTION FOR AN ACUTE COMPLICATION OF DIABETES. DURING THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE PATIENT WAS USING THE SAME APPROVED SAMPLE SITE TO OBTAIN THE SAMPLES. THE CCA NOTED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT DURING THE TIME OF TESTING. THE CCA DOCUMENTED THAT THE PATIENT'S TESTING PROCESS WAS CORRECT AND HER TEST STRIPS AND TEST STRIP VIAL WERE IN GOOD CONDITION. 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 SYMPTOMS DO NOT MEET LFS' CRITERIA FOR A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS OR TREATMENT SUGGESTIVE THAT AN ACUTE COMPLICATION OF DIABETES OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING DONE BY THE CCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1