BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT SELECT SIMPLE METER

    MDR report key: 8649205 · Received May 29, 2019

    Report

    Report Number
    3008382007-2019-01821
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Report Date
    April 22, 2019
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO A LABORATORY DEVICE. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿255 MG/DL¿ WITH THE SUBJECT METER AND ¿135 MG/DL¿ ON THE LABORATORY DEVICE. THE TESTS WERE PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT IN ADDITION COMPLAINTS RELATING TO THE REPORTED PRODUCT(S) WERE EVALUATED. IT WAS CONCLUDED THAT THE NUMBER OF COMPLAINTS FOR THE PRODUCT(S) DID NOT BREACH THRESHOLDS INDICATIVE OF A SYSTEMIC ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444507 OT SELECT SIMPLE METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1