BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2802271 · Received October 23, 2012

    Report

    Report Number
    3008382007-2012-05488
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    October 1, 2012
    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

    (B)(4): THE TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE TESTED WITH CONTROL SOLUTION AND WAS FOUND TO BE OUT OF THE CONTROL SOLUTION RANGE. 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

    FOLLOW-UP # 1 (02/14/2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED ON (B)(4) 2012 AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER PASSED TESTING WITH NO FAULTS FOUND. THE METER MET SPECIFICATION AND WAS FOUND TO FUNCTION PROPERLY. 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) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) IN (B)(4), ALLEGING A ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH RESULTS COMPARED TO ANOTHER METER. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE VALUES OF "10.6MMOL/L" ON THE LFS METER AND "5.8MMOL/L" ON ANOTHER FREESTYLE METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=1.17MMOL/L OR <=30% OBTAINED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY DUE TO THE REPORTED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THE SUBJECT METER DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS OR TREATMENT SUGGESTIVE THAT A SERIOUS INJURY OCCURRED. IN ADDITION THE PATIENT PERFORMED A METER VS. ANOTHER METER COMPARISON WHERE THE CALCULATED DIFFERENCE BETWEEN THE RESULTS MEETS LFS CRITERIA FOR ACCURACY REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3255861

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR