BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3052819 · Received April 11, 2013

    Report

    Report Number
    3008382007-2013-07592
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 18, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING SHE WAS HAVING DIFFICULTY INSERTING THE TEST STRIP IN TO HER ONETOUCH VERIOIQ METER. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE OCCURRED ON (B)(6) 2013 (AT 8:45AM). AT AN UNSPECIFIED DATE/TIME PRIOR TO THE START OF THE ALLEGED ISSUE THE PATIENT REPORTEDLY EXPERIENCED A SYMPTOM OF SHAKING. THERE IS NO INDICATION THE PATIENT RECEIVED ANY FORM OF MEDICAL INTERVENTION AFTER THE ALLEGED ISSUE OCCURRED. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME AND THERE WAS NO MISUSE OF THE LFS PRODUCT. THERE IS NO EVIDENCE THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS PRIOR TO THE ALLEGED PRODUCT ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154277 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3241786

    Patients

    Seq Age Sex Outcome Treatment
    1