BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 3132380 · Received May 29, 2013

    Report

    Report Number
    3008382007-2013-13337
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 6, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K093745
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER ASSOCIATED WITH THIS COMPLAINT HAS BEEN RETURNED TO LIFESCAN; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (05/20/2013)-DEVICE EVALUATION: THE LAY USER/PATIENT¿S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE SYSTEM INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE LFS TEST STRIP VIAL CONTAINED THE INCORRECT TEST STRIPS. 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 USA, ALLEGING STRIP ISSUE. THE REPORTER INDICATED THAT THE STRIP WAS MISSING "GOLD CHANNEL AND DID NOT SEEM TO FIT IN METER." 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
    235587 OT VERIO TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3418733

    Patients

    Seq Age Sex Outcome Treatment
    1