BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 2863550 · Received December 10, 2012

    Report

    Report Number
    3008382007-2012-07409
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 14, 2012
    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
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE EVALUATION: THE TEST STRIPS INVOLVED IN THIS COMPLAINT HAVE BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE FAILED TESTING. DUE TO EXCESS GLUE PRESENT ON SIDES OF STRIPS TEST STRIPS ARE STICKING TOGETHER. 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) 2012 THE REPORTER CONTACTED LIFESCAN (LFS) IN (B)(4) ALLEGING THE TEST STRIPS WERE STICKING TOGETHER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVE WITH TROUBLESHOOTING DONE BY THE CUSTOMER CARE ADVOCATE (CCA). THERE WAS NO INDICATION THAT THE LFS PRODUCT CAUSED OR CONTRIBUTED TO A ADVERSE EVENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE TEST STRIPS INVOLVED IN THIS COMPLAINT HAVE BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE FAILED TESTING. DUE TO EXCESS GLUE PRESENT ON SIDES OF STRIPS TEST STRIPS ARE STICKING TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR