BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2192769 · Received August 5, 2011

    Report

    Report Number
    3008382007-2011-00157
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    July 14, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 LAY USER / PATIENT FROM (B)(6) CONTACTED LFS VIA LETTER ALLEGING AN ERROR 4 MESSAGE ON THEIR ONE TOUCH VERIO METER. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THE PATIENT DID NOT INDICATE ANY SYMPTOMS AND DID NOT INDICATE THAT THE RECEIVED ANY MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE. THE COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED ERROR 4 MESSAGE

    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