BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2802196 · Received October 23, 2012

    Report

    Report Number
    3008382007-2012-05477
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    September 28, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) IN (B)(4) ALLEGING A ONETOUCH VERIO PRO METER WAS DISPLAYING AN UNKNOWN ERROR MESSAGE. THE PATIENT REPORTED IT READ "INSUFFICIENT BLOOD ON SAMPLE, COULD HAVE BEEN AN ERROR 4 OR 5." THE PATIENT DID NOT ALLEGE ANY HARM OR INJURY DUE TO THE ALLEGED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION(S): THERE IS NO INDICATION THAT SUBJECT METER CAUSE OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS, SYMPTOMS OR TREATMENT SUGGESTIVE THAT AN ACUTE COMPLICATION OF DIABETES OCCURRED. HOWEVER THIS COMPLAINT IS BEING REPORTED BECAUSE, THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    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 43 YR