BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2932636 · Received January 29, 2013

    Report

    Report Number
    3008382007-2013-01724
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 16, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE TEST STRIP HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED TESTING AND MET SPECIFICATION; PA UNABLE TO REPRODUCE COMPLAINT DURING INVESTIGATION. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE ONETOUCH VERIO IQ METER READ INACCURATELY ERRATIC. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "407, 213, 210 AND 316 MG/DL" AND "363 MG/DL" AND "104 AND 209 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION BECAUSE OF THE REPORTED ISSUE. AS THE RESULTS FELL OUTSIDE EXPECTED VALUES FOR PRECISION TESTING, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38475 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3376682

    Patients

    Seq Age Sex Outcome Treatment
    1