BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3092143 · Received May 3, 2013

    Report

    Report Number
    3008382007-2013-10071
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 9, 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 (B)(6) CONTACTED LIFESCAN (LFS) TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING INACCURATE READINGS. THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 225 MG/DL AND 87 MG/DL ON THE REPORTED METER WITHIN 20 MINUTES. THE PATIENT'S TESTING TECHNIQUE WAS CORRECT; NO INFORMATION WAS PROVIDED ABOUT THE TEST STRIPS CONDITION. THE PATIENT DID NOT REPORT EXPERIENCING ANY SYMPTOMS OR MEDICAL ATTENTION. THE PATIENT DID NOT SUFFER ANY INJURY DUE TO THE REPORTED METER. THE PATIENT EXPERIENCED NO SYMPTOMS AND DENIED SEEING MEDICAL ATTENTION. HOWEVER, AS THE TEST RESULTS FELL OUTSIDE EXPECTED VALUES FOR PRECISION TESTING, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194474 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR