BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2220993 · Received August 23, 2011

    Report

    Report Number
    3008382007-2011-00242
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Report Date
    July 12, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE (510) K # IS K093745. THE METER AND TEST STRIPS WERE RETURNED TO LIFESCAN FOR INVESTIGATION. THE METER WAS TESTED AND PASSED TESTING AND THE ERROR 2 MESSAGE WAS NOT CONFIRMED; HOWEVER, A SECONDARY ISSUE OF AN ERROR 4 WAS FOUND WHILE INVESTIGATING THE SUBJECT TEST STRIPS.

    Description of Event or Problem · 1

    THE LAY REPORTER/ PHYSICIAN CONTACTED LFS (B)(4) BY LETTER ON (B)(6) 2011 ALLEGING AN ERROR 2 MESSAGE ON THE ONE TOUCH VERIO PRO METER. BASED ON THE INFORMATION THAT WAS PROVIDED, IT WAS MENTIONED THAT THIS WAS THE FIRST TIME THAT THE REPORTER HAD BEEN USING THE PRODUCT. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE ALLEGED ISSUE. THE METER AND TEST STRIPS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION. AT THIS TIME THERE IS NO INFORMATION THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT OR THAT A PATIENT EXHIBITED ANY SYMPTOMS SINCE NO FURTHER CLINICAL INFORMATION WAS PROVIDED. THE COMPLAINT IS BEING REPORTED SINCE THE ALLEGED ISSUE WAS NOT RESOLVED.

    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 3083767

    Patients

    Seq Age Sex Outcome Treatment
    1