BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2193021 · Received August 5, 2011

    Report

    Report Number
    3008382007-2011-00158
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    July 23, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4), 2011 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. LIFESCAN (LFS) HAS REQUESTED THE RETURN OF THE TEST STRIPS FOR EVALUATION. IF THE TEST STRIPS ARE RETURNED LFS WILL EVALUATE THEM AND INFORM FDA OF THOSE FINDINGS IN A SUPPLEMENTAL REPORT. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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 / COMPARED HIS VERIO METER TO HIS ONE TOUCH ULTRA METER. THE PATIENT OBTAINED A 169MG/DL AND 242 MG/DL ON HIS VERIO METER AN COMPARED THE READINGS TO HIS ONE TOUCH ULTRA OF 94MG/DL AND 210MG/DL. THE PATIENT DENIED SEEKING ANY MEDICAL ATTENTION OR CONTACTING HIS PHYSICIAN FOR ASSISTANCE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE READINGS ARE GREATER THAN 30 MG/DL (1.7 MMOL/L) OR 30%

    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 52 YR