BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO2 METER

    MDR report key: 4150722 · Received October 8, 2014

    Report

    Report Number
    2939301-2014-26777
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    October 1, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K131363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S METER HAS BEEN RETURNED ON 11/14/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 2/3/2015 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. 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 # 1 ¿ (12/03/2014). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 10/28/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 11/24/2014 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE FOUND TO HAVE RESULTS GREATER THAN +50% OF THE CONTROL SOLUTION WHEN TESTED WITH CONTROL SOLUTION. 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 BE SATURATED BY MOISTURE AND FAILED TGA TESTING. 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

    CORRECTION 09/08/2015: ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING INACCURATELY HIGH CONTROL SOLUTION RESULTS. THE REPORTER OBTAINED A CONTROL SOLUTION READING OF "179MG/DL" ON THE SUBJECT METER (ONETOUCH VERIO2). THIS FALLS OUT WITH THE CONTROL SOLUTION RANGE OF "102-138MG/DL" FOR THIS STRIP LOT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN¿S ACCURACY 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 ¿ (12/03/2014). THE PATIENT¿S CONTROL SOLUTION HAS BEEN RETURNED ON 10/28/2014 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/3/2014 WITH THE FOLLOWING FINDINGS:THE CONTROL SOLUTION INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE EVALUATED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED; HOWEVER, A SECONDARY ISSUE WAS NOTED WHEN THE CONTROL SOLUTION WAS FOUND TO HAVE LOW GLUCOSE RESULTS WHEN TESTED WITH CONTROL SOLUTION. 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 INACCURATE RESULTS. 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
    632870 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3605681

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR