BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 5842301 · Received August 3, 2016

    Report

    Report Number
    3008382007-2016-39517
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Report Date
    July 24, 2016
    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
    HI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES FOR THE DHR REVIEW WAS OMITTED FROM SUPPLEMENTAL #1 DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE SUBJECT TEST STRIP LOT. THE REVIEW DID NOT IDENTIFY ANYTHING THAT COULD ADVERSELY IMPACT PRODUCT PERFORMANCE OR FUNCTION.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS FAILED TESTING. THE REPORTED ISSUE WAS CONFIRMED. ADDITIONAL TESTS WERE PERFORMED ON THE TEST STRIP VIAL AND THE DESICCANT TO CHECK THE STRUCTURAL INTEGRITY AND FOR POSSIBLE MOISTURE ISSUE. THE STRUCTURAL INTEGRITY OF THE TEST STRIP VIAL WAS FOUND TO BE INTACT DURING A GROSS LEAK TEST. THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND TO CONTAIN MORE MOISTURE THAN EXPECTED FROM NORMAL USE (AS PER PRODUCT LABELLING). 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) 2016, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING OBTAINING AN INACCURATE HIGH BLOOD GLUCOSE RESULT OF ¿250, 236, 259, 254, 224, 240 AND 256 MG/DL¿ COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. AT THE TIME OF TROUBLESHOOTING, THE REPORTER PERFORMED A CONTROL SOLUTION TEST AND THE RESULT FELL OUTSIDE OF THE SPECIFIED CONTROL SOLUTION RANGE. THIS COMPLAINT IS BEING REPORTED BECAUSE 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
    497938 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3946849

    Patients

    Seq Age Sex Outcome Treatment
    1