BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3010078 · Received March 19, 2013

    Report

    Report Number
    3008382007-2013-05532
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    February 20, 2013
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT METER, TEST STRIPS AND CONTROL SOLUTION WERE RETURNED TO LFS. HOWEVER THE EVALUATION OF THE PRODUCTS HAS NOT YET BEEN COMPLETED. THEREFORE NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER WAS EVALUATED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. PA WAS UNABLE TO REPRODUCE THE COMPLAINT. THE CONTROL SOLUTION AND TEST STRIPS BOTH PASSED TESTING WITH NO FAULTS FOUND. 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 USA, ALLEGING INACCURATE RESULTS WITH CONTROL SOLUTION WITH READINGS OF "258 AND 420 MG/DL". 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
    113796 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3362699

    Patients

    Seq Age Sex Outcome Treatment
    1