BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 3163048 · Received June 11, 2013

    Report

    Report Number
    3008382007-2013-16674
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 29, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K093745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (09/02/2013). THE PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 8/13/2013 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 8/28/2013 AND 8/29/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE TEST STRIPS WERE ALSO TESTED AND IT WAS FOUND TO HAVE RESULTS ABOVE RANGE WHEN TESTED WITH CONTROL SOLUTION. 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) (B)(6) ALLEGING THE ONETOUCH VERIO METER READ INACCURATELY ERRATIC. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF ¿10, 12.7, AND 13.4 MMOL/L¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION BECAUSE OF THE REPORTED ISSUE. AS THE RESULTS FELL OUTSIDE EXPECTED VALUES FOR PRECISION TESTING, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263710 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3351640

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR