BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2190521 · Received August 4, 2011

    Report

    Report Number
    3008382007-2011-00150
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Report Date
    July 15, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. THE 510 (K) # IS K093745

    Description of Event or Problem · 1

    THE PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2011 ALLEGING AN APPLY SAMPLE MESSAGE ON THEIR ONE TOUCH VERIO PRO METER. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE. THE CUSTOMER CARE ADVOCATE (CCA) WALKED THE PATIENT THROUGH THE PROPER TESTING TECHNIQUE AND THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE. THE METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR