BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3212316 · Received July 9, 2013

    Report

    Report Number
    3008382007-2013-19098
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 10, 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
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING AN UNSPECIFIED ERROR MESSAGE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED AN UNSPECIFIED ERROR MESSAGE ON THE REPORTED METER INDICATING ¿NOT ENOUGH BLOOD¿. THE PATIENT REPORTED THAT SHE WAS ABLE TO ALSO OBTAIN THE READINGS OF 400 MG/DL AND 500 MG/DL ON THE REPORTED METER. THE ERROR MESSAGE ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. HOWEVER, AS THE ERROR MESSAGE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311931 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3382772

    Patients

    Seq Age Sex Outcome Treatment
    1