BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3173752 · Received June 17, 2013

    Report

    Report Number
    3008382007-2013-17476
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 21, 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 (LFS) TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING INACCURATELY ERRATIC READINGS. THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 388 MG/DL AND 173 MG/DL ON THE REPORTED METER WITHIN 20 MINUTES. THE PATIENT¿S TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING AND THE TESTING TECHNIQUE WAS CORRECT. THE PATIENT EXPERIENCED NO SYMPTOMS AND DENIED SEEKING MEDICAL ATTENTION. THE PATIENT DID NOT SUFFER ANY INJURY DUE TO THE REPORTED METER. THE PATIENT EXPERIENCED NO SYMPTOMS AND HE DENIED SEEKING MEDICAL ATTENTION. HOWEVER AS THE TEST RESULTS FELL OUTSIDE EXPECTED VALUES FOR PRECISION TESTING THIS COMPLAINT IS BEING REPORTED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274074 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3421501

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR