BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 5719491 · Received June 12, 2016

    Report

    Report Number
    3008382007-2016-28838
    Event Type
    Injury
    Date Received
    June 12, 2016
    Date of Event
    May 8, 2016
    Report Date
    June 4, 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
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS METER AND TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER AND 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.

    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 JUNE 5, 2016 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH VERIOIQ METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT CLAIMED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2016 AT 12:43AM WHEN HE OBTAINED A BLOOD GLUCOSE RESULT OF 485MG/DL USING THE SUBJECT DEVICE WHICH HE FELT WAS ELEVATED COMPARED TO HIS FEELINGS AND/OR USUAL RESULTS. IN A RELATED COMPLAINT (SAME TEST STRIP LOT # 3923616) THE PATIENT ALLEGED THAT THE METER WAS READING INACCURATE ERRATICALLY, WHEN HE ALLEGEDLY OBTAINED READINGS OF 485 AND 380MG/DL USING THE SUBJECT DEVICE, WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE DIFFERENCE BETWEEN THESE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR PRECISION. THE PATIENT MANAGES HIS DIABETES USING INSULIN (SELF-ADJUSTER) AND REPORTEDLY INCREASED HIS DOSE OF NOVOLIN-N INSULIN BY AN ADDITIONAL 8-10 UNITS ON (B)(6) AT 12:43AM IN RESPONSE TO THE REPORTED ISSUE. THE PATIENT CLAIMED EXPERIENCING SYMPTOMS OF SHAKY AND SWEATY APPROXIMATELY 3 WEEKS AFTER THE ALLEGED ISSUE BEGAN AND DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION IN RESPONSE TO THE REPORTED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE TEST STRIPS HAD BEEN STORED CORRECTLY AND WITHIN EXPIRY, AN APPROVED SAMPLE SITE WAS BEING USED AND THE PATIENT¿S TESTING TECHNIQUE WAS CORRECT. THE CSR WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST AND THE RESULT FELL WITHIN THE EXPECTED RANGE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, TOOK ACTION BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373972 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3923616

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening