BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2232810 · Received September 2, 2011

    Report

    Report Number
    3008382007-2011-00310
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 8, 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

    THE 510 (K) # IS K093745. LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. LFS HAS RECEIVED THE METER BACK FOR TESTING AND THE METER WAS EVALUATED AND THE METER PASSED TESTING. IF THE TEST STRIPS 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) ON (B)(6) 2011 ALLEGING INACCURATE HIGH READINGS ON THEIR ONE TOUCH VERIO PRO METER. THE PATIENT COMPARED THEIR ONE TOUCH VERIO PRO METER TO ANOTHER METER. THE PATIENT HAD OBTAINED A 120 MG/DL ON THE ONE TOUCH VERIO PRO METER AND LESS THAN 30 MINUTES LATER OBTAINED AN 85 MG/DL ON AN ULTRAEASY METER. THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS DUE TO THE ALLEGED ISSUE OR SEEK ANY MEDICAL ATTENTION DUE TO THE DISCREPANCY OF THE READINGS. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE PRODUCTS WERE REPLACED AND REQUESTED BACK. THE COMPLAINT IS BEING REPORTED SINCE THE DIFFERENCE BETWEEN THE TWO READINGS ARE GREATER THAN 30 MG/DL 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 3113423

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR