BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 3142985 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14701
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 20, 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 ¿ (09/22/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 9/10/2013 AND 9/14/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED ON 07/31/2013 FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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 REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING INACCURATE RESULTS. THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS OF ¿7.1, 5.7 AND 4.3 MMOL/L¿ WITH THE LIFESCAN METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN¿S ACCURACY/PRECISION CRITERIA AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243381 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3360178

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR