BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3193549 · Received June 27, 2013

    Report

    Report Number
    3008382007-2013-18621
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 27, 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
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE LAY USER/PATIENT IN FRANCE CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2013 THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 122 MG/DL ON THE REPORTED METER AND A LABORATORY RESULT OF 86 MG/DL WITHIN 10 MINUTES. AT THAT TIME THE PATIENT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. THE PATIENT TOOK THE ACTION OF CONSUMING LESS SUGAR IN HER DIET; SHE DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. TROUBLESHOOTING REVEALED THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING AND THE PATIENT¿S TESTING TECHNIQUE WAS CORRECT. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. THE PATIENT SUFFERED NO SYMPTOMS AND DENIED SEEKING MEDICAL ATTENTION. HOWEVER, AS THE TEST RESULTS FELL OUTSIDE EXPECTED VALUES FOR METER-TO-LAB ACCURACY TESTING, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293813 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3398960

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR