BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4131138 · Received October 1, 2014

    Report

    Report Number
    2939301-2014-26015
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 26, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 - 3/25/2015 DEVICE EVALUATION. THE LAY USER/PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 11/13/2014 AND 11/13/2014, EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/1/2014 AND 12/10/2014 RESPECTIVELY WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED.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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (B)(4) ALLEGING THAT THEIR ONETOUCH VERIOIQ METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN ¿IN THE EVENING, ABOUT A WEEK AGO¿ WHEN A READING OF ¿8.2MMOL/L¿ WAS OBTAINED USING THE SUBJECT METER AND COMPARED TO A READING OF ¿4.8MMOL/L¿ OBTAINED USING AN ACCUCHECK AVIVA DEVICE. BOTH READINGS WERE TAKEN WITHIN 30 MINUTES OF EACH OTHER AND WERE FROM THE SAME BLOOD SAMPLE. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THE PATIENT MANAGES THEIR DIABETES WITH A COMBINATION OF DIABETES MEDICATIONS, SPECIFICALLY ¿VICTOZA, GLUMETZA AND LEVEMIR¿. IN RESPONSE TO ALLEGED ELEVATED RESULT, THE PATIENT REPORTED TAKING AN ADDITIONAL 2 UNITS OF LEVEMIR INSULIN AT 11.45PM. THE PATIENT STATED THAT THEY DID NOT DEVELOP ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. THE PATIENT ALSO DENIED RECEIVING ANY MEDICAL INTERVENTION DUE TO THE ALLEGED PRODUCT ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE CORRECT TESTING PROCEDURE WAS BEING USED AND THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE CSR WAS UNABLE TO WALK THE PATIENT THROUGH A CONTROL SOLUTION TEST AND THE ISSUE REMAINED UNRESOLVED. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA OR HYPERGLYCEMIA, NOR RECEIVE MEDICAL INTERVENTION FOR EITHER OF THESE CONDITIONS. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE ALLEGED METER/PRODUCT ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612175 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3623393

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR