BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VITA METER

    MDR report key: 2190754 · Received August 4, 2011

    Report

    Report Number
    3008382007-2011-00152
    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
    BE
    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)S # IS K093745.

    Description of Event or Problem · 1

    FACILITY FROM (B)(6) CONTACTED LFS ALLEGING A DATE/TIME ISSUE WITH THEIR ONE TOUCH VERIO METER. THIS IS THE FIRST TIME THEY ARE USING THE METER. SHE DENIED ANYONE EXHIBITED ANY SYMPTOMS OR SOUGHT ANY MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE WITH THE CUSTOMER CARE ADVOCATE (CCA). THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE ALLEGED ISSUE WITH THE VERIO WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VITA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3140336

    Patients

    Seq Age Sex Outcome Treatment
    1