BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 2810308 · Received October 31, 2012

    Report

    Report Number
    3008382007-2012-05807
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    May 24, 2011
    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
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER CONTACTED LIFESCAN (LFS) ALLEGING AN "ERROR 2" ISSUE WITH THE SUBJECT METER. THIS COMPLAINT WAS INITIALLY NOT REPORTED SINCE THE REPORTED ISSUE WAS RESOLVED WITH TROUBLESHOOTING WITH CUSTOMER SERVICE. THERE WAS ALSO NO ALLEGATION OF HARM AS A RESULT OF THE REPORTED ISSUE. LFS RECEIVED THE PRODUCTS INVOLVED WITH THE COMPLAINT (METER ON (B)(4) 2011 AND TEST STRIPS ON (B)(4) 2011. INVESTIGATION DID NOT CONFIRM THE ALLEGED COMPLAINT WITH THE RETURNED METER AND TEST STRIPS; HOWEVER, THERE WAS A SECONDARY ISSUE FOUND WITH THE RETURNED TEST STRIPS. THE CONTROL SOLUTION TEST WAS ABOVE EXPECTED RANGE WITH THE RETURNED TEST STRIPS. THIS COMPLAINT IS NOW BEING REPORTED DUE TO THE SECONDARY ISSUE FOUND WITH THE TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3048502

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR