BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2190152 · Received August 4, 2011

    Report

    Report Number
    3008382007-2011-00148
    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

    THE 510 (K) # IS K093745. 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.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS (B)(4) ALLEGING INACCURATE READINGS ON THE PATIENT'S ONE TOUCH VERIO METER. THE PATIENT OBTAINED A 130 MG/DL AND A 155 MG/DL WITHIN 20 MINUTES FROM ONE ANOTHER. THE PATIENT DENIED EXHIBITING ANY SYMPTOMS OR SEEKING ANY MEDICAL ATTENTION. THE COMPLAINT IS BEING REPORTED SINCE THE READING ARE GREATER THAN 15 % AND MEET THE CRITERIA FOR REPORTING THE MALFUNCTION.

    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 3118426

    Patients

    Seq Age Sex Outcome Treatment
    1