BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 5767962 · Received July 4, 2016

    Report

    Report Number
    3008382007-2016-33600
    Event Type
    Injury
    Date Received
    July 4, 2016
    Report Date
    June 27, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THEIR ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH COMPARED TO A ONETOUCH SELECT SIMPLE METER. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED INACCURACY HAD OCCURRED BETWEEN 12 AND 1PM ON (B)(6) 2016. AT THIS TIME THE PATIENT OBTAINED RESULTS OF "EITHER 5.7 OR 5.8MMOL/L" WITH THE SUBJECT METER AND "3.5MMOL/L" ON THE OTHER METER WITHIN 30 MINUTES OF ONE ANOTHER. THE PATIENT DID NOT SPECIFY WHAT MEDICATION, IF ANY, THEY TAKE TO MANAGE THEIR DIABETES NOR IF THEY HAD MADE ANY CHANGES TO THEIR NORMAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED PRODUCT ISSUE. THE PATIENT STATED THAT THEY IMMEDIATELY EXPERIENCED THE SYMPTOM OF "TREMOR" WHICH THEY ASSOCIATED WITH LOW BLOOD GLUCOSE LEVELS. IN RESPONSE TO THIS SYMPTOM THE PATIENT SELF-TREATED BY CONSUMING FOOD AND/OR DRINK. NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE ALLEGED PRODUCT ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. THE CSR WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST AND IT FELL WITHIN THE CONTROL RANGE. THE PATIENT'S PRODUCTS WERE REPLACED AND REQUESTED FOR EVALUATION. ALTHOUGH DURING TROUBLESHOOTING IT WAS FOUND THAT THE PATIENT'S METER FELL WITHIN AN ACCEPTABLE RANGE WITH A CONTROL SOLUTION TEST, AND THEREFORE A MALFUNCTION CAN BE RULED OUT, THIS COMPLAINT IS STILL BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS INDICATIVE OF SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422023 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3948261

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening