BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO SYNC METER

    MDR report key: 4183380 · Received October 18, 2014

    Report

    Report Number
    2939301-2014-27875
    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
    K120708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (02/09/2015). THE PATIENT¿S TEST STRIPS HAVE BEEN RETURNED ON 1/13/2015 AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 1/26/2015 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. WHEN TEST STRIPS WERE TESTED WITH CONTROL SOLUTION, AN ERROR 4 WAS OBSERVED 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 # 3 ¿ (03/18/2015) CORRECTION.SUPPLEMENTAL SENT TO CORRECT ALERT DATE. ALERT DATE SHOULD HAVE STATED 03/10/2015.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 - 3/18/2015 DEVICE EVALUATION.THE LAY USER/PATIENTS METER HAS BEEN RETURNED ON 2/27/2015 AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 3/10/2015 WITH THE FOLLOWING FINDINGS:ERROR MESSAGE 4 OBSERVED IN THE ERROR LOG, BUT THE ERRORS WERE NOT REPRODUCED DURING THE INVESTIGATION. 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 USA, ALLEGING ERROR 4. 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
    663896 OT VERIO SYNC METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3645791

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR