BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 3090902 · Received May 2, 2013

    Report

    Report Number
    3008382007-2013-09946
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Report Date
    April 4, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K093745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 3 ¿ (07/12/2013). THE PATIENT¿S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/27/2013 AND 7/9/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS:THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO BE UNABLE TO REPRODUCE AN ERROR 2 MESSAGE. 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 (06/26/2013)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/20/2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE PASSED TESTING WITH NO FAULTS FOUND; THE 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. THE MFR NARRATIVE HAS BEEN CORRECTED TO SHOW THAT ONLY THE TEST STRIPS HAVE BEEN TESTED. FOLLOW UP #1 MADE AN INCORRECT REFERENCE TO METER TESTING WHICH SHOULD BE DISREGARDED; THE METER HAS NOT YET BEEN TESTED.

    Additional Manufacturer Narrative · 1

    THE LFS PRODUCT(S) HAS BEEN REQUESTED FOR RETURN TO LIFESCAN FOR EVALUATION. IF THE SUBJECT PRODUCT IS RETURNED, AN EVALUATION WILL BE COMPLETED AND THE FINDINGS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (06/26/2013)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/20/2013 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND; THE 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) 2013, 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
    193041 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR