BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3112958 · Received May 14, 2013

    Report

    Report Number
    3008382007-2013-11523
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 19, 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
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING THE METER WAS DISPLAYING AN ERROR 2 MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO FOLLOW UP WITH THE PATIENT PER THE PATIENT'S REQUEST. THIS COMPLAINT WAS CLASSIFIED USING THE DOCUMENTATION PROVIDED BY THE CUSTOMER CARE ADVOCATE (CCA). THE REPORTER STATED DUE TO THE ALLEGED ISSUE, SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE. THE REPORTER STATED SINCE THE START OF THE ALLEGED ISSUE, SHE HAS BEEN FEELING SYMPTOMS OF "DIZZINESS." THE REPORTER WAS UNABLE TO PROVIDE WHEN THE ALLEGED ISSUE FIRST STARTED. THE REPORTER DENIED RECEIVING ANY TREATMENT IN RESPONSE TO HER SYMPTOMS. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S REPORTED SYMPTOMS DO NOT MEET LFS' CRITERIA FOR 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 REMAINED UNRESOLVED WITH TROUBLESHOOTING DONE BY THE CCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211996 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3387609

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR