BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2170967 · Received July 21, 2011

    Report

    Report Number
    3008382007-2011-00050
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    June 21, 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 METER WAS RETURNED FOR INVESTIGATION. THE METER WAS EVALUATED AND PASSED TESTING, WITH NO PROBLEMS FOUND.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONETOUCH VERIO PRO METER WAS GIVING INACCURATE READINGS. THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF 256 MG/DL ON THE REPORTED METER AND A READING OF 190 MG/DL ON ANOTHER METER WITHIN 30 MINUTES. THE PATIENT'S TESTING TECHNIQUE AND TEST STRIPS WERE CORRECT. THE PATIENT SUFFERED NO INJURY DUE TO THIS ISSUE. THE METER AND TEST STRIPS WERE REPLACED.

    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 78 YR