BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3230161 · Received July 16, 2013

    Report

    Report Number
    3008382007-2013-19941
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 24, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT¿S ONETOUCH VERIO IQ METER WAS DISPLAYING AN UNKNOWN ERROR MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW UP CALL IN (B)(4) 2013. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON AN UNKNOWN DATE SOMETIME IN (B)(6) 2013. SHE REPORTED ATTEMPTING TO TEST WITH THE SUBJECT METER AND GETTING AN ERROR MESSAGE INSTEAD OF A READING. THE PATIENT MANAGES HER DIABETES WITH A MEALTIME INSULIN ¿R¿ AT BREAKFAST AND AT LUNCH AND STATED SHE ATE SOMETHING SWEET PRIOR TO TAKING HER MEALTIME INSULIN TO CORRECT FOR ANY LOWS SHE MIGHT GET. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE AND DID NOT RECEIVE ANY MEDICAL INTERVENTION DUE TO THE ALLEGED ISSUE. NO OTHER DEVICE WAS USED FOR TESTING. THE PATIENT DID NOT HAVE THE SUBJECT METER WITH HER AT THE TIME OF THE CALL. THE METER WAS NOT BEING USED FOR THE FIRST TIME. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THE PATIENT DENIED DEVELOPING SYMPTOMS OR RECEIVING ANY FORM OF MEDICAL INTERVENTION AS A RESULT OF THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329965 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR