BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 3972525 · Received August 1, 2014

    Report

    Report Number
    2939301-2014-19288
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Report Date
    July 24, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (09/29/2014). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 8/22/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 9/18/2014 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE EVALUATED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED; HOWEVER, A SECONDARY ISSUE WAS NOTED WHERE AN ASSAY DID NOT START DURING CONTROL SOLUTION TESTS WITH NO ASSIGNABLE CAUSE FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (11/05/2014). THE PATIENT¿S METER HAS BEEN RETURNED ON 9/25/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 10/23/2014 WITH THE FOLLOWING FINDINGS: ERROR MESSAGE 2 IS OBSERVED IN THE ERROR LOG, BUT ERROR WAS NOT REPRODUCED DURING THE INVESTIGATION. IN ADDITION, A SECONDARY ISSUE WAS NOTED WHEN THE METER WAS FOUND TO HAVE A CORRODED BATTERY CONTACT. 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 2. 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
    449740 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3653395

    Patients

    Seq Age Sex Outcome Treatment
    1