BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 3479577 · Received November 20, 2013

    Report

    Report Number
    2939301-2013-08468
    Event Type
    Injury
    Date Received
    November 20, 2013
    Report Date
    November 18, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LFS PRODUCT(S) HAS/HAVE BEEN REQUESTED FOR RETURN TO LIFESCAN FOR EVALUATION. IF THE PRODUCT IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 AND (B)(4) 2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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) IN (B)(4) ALLEGING HIS ONETOUCH VERIOIQ METER WAS DISPLAYING INACCURATELY HIGH RESULTS COMPARED TO ANOTHER 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 THE ALLEGED ISSUE FIRST OCCURRED AT AN UNKNOWN TIME. THE PATIENT REPORTED READINGS OF ¿142, 151, 144, AND 145 MG/DL¿ WERE OBTAINED ON THE LFS METER COMPARED TO ¿115, 127, 108, AND 118 MG/DL¿ ON ANOTHER METER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <30MG/DL OR <30% OBTAINED WITHIN 30 MINUTES OF ONE ANOTHER. THE PATIENT REPORTED USING SELF-ADJUSTING INSULIN TO MANAGE HIS DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED HE DEVELOPED SYMPTOMS OF ¿DIZZINESS, SWEATING AND BLURRED VISION¿ WHICH HE ASSOCIATED WITH HYPOGLYCEMIA BETWEEN (B)(6) 2013 AND (B)(6) 2013. THE PATIENT REPORTED IN RESPONSE TO THE SYMPTOMS HE HAD SOMETHING TO EAT OR DRINK AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE CCA CONFIRMED THE PATIENT WAS USING THE CORRECT TESTING STEPS, AND AN APPROVED SAMPLE SITE. THE PATIENT¿S TEST STRIPS AND TEST STRIPS VIAL WERE IN GOOD CONDITION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE, HE WAS UNABLE TO CONTROL HIS BLOOD GLUCOSE EFFECTIVELY, AND THEREFORE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602771 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3388054

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R