BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO TEST STRIPS

    MDR report key: 2192707 · Received August 5, 2011

    Report

    Report Number
    3008382007-2011-00156
    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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (09/13/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. 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. LOT # OF TEST STRIPS WAS NOT PROVIDED. THE #(510K) K093745.

    Description of Event or Problem · 1

    THE PATIENT FROM (B)(6) CONTACTED LFS ALLEGING THAT HE IS NO LONGER ABLE TO INSERT THE TEST STRIPS INTO THE METER. PATIENT IS USING THE CORRECT TEST STRIPS FOR HIS ONE TOUCH VERIO METER. THE PATIENT DENIED EXHIBITING ANY SYMPTOMS OR RECEIVING ANY MEDICAL TREATMENT DUE TO THE ALLEGED ISSUE. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT HE WAS UNABLE TO TEST DUE TO THE VERIO TEST STRIPS NOT BEING ABLE TO FIT INTO HIS VERIO METER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR