BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4183419 · Received October 18, 2014

    Report

    Report Number
    2939301-2014-27840
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Report Date
    October 10, 2014
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (12/21/2014), THE PATIENT¿S TEST STRIPS #3593151 AND #3533870 HAVE BEEN RETURNED ON 11/4/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/9/2014 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS #3593151 WERE EVALUATED AND THE REPORTED ISSUE COULD NOT BE CONFIRMED; HOWEVER, A SECONDARY ISSUE WAS NOTED WHEN THE TEST STRIPS #3593151 WERE EVALUATED AND FOUND TO BE MISCLASSIFIED BY THE METER. A TERTIARY ISSUE WAS NOTED WHEN THE TEST STRIPS #3593151 WERE FOUND TO HAVE RESULTS BELOW RANGE WHEN TESTED WITH CONTROL SOLUTION. THE TEST STRIPS #3533870 WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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) 2014, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING ERROR UNKNOWN. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664005 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3636019

    Patients

    Seq Age Sex Outcome Treatment
    1