BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2853880 · Received December 3, 2012

    Report

    Report Number
    3008382007-2012-06994
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 9, 2012
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (1/14/2013)-DEVICE EVALUATION: THE METER AND TEST STRIP INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 AND (B)(4) 2012 RESPECTIVELY WITH THE FOLLOWING FINDINGS: THE TEST STRIP RESULTS WERE OUTSIDE THE CONTROL SOLUTION RANGE. HOWEVER, THE REPORTED INACCURATE HIGH ISSUE COULD NOT BE REPRODUCED ON THE SUBJECT METER. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. DEVICE RETURNED TO MFG DATE: TEST STRIPS - (B)(6) 2012, METER - (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    THE SUBJECT METER AND TEST STRIPS HAVE BEEN RETURNED TO LIFESCAN FOR EVALUATION. THE EVALUATION OF THE PRODUCTS HAVE NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED LIFESCAN (LFS) IN (B)(6) ALLEGING THE ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE REPORTER ALLEGED READINGS OF "10.2MMOL/L" ON THE LFS METER COMPARED TO "8.2MMOL/L" ON A BACK UP ONETOUCH ULTRA2 METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN'S ACCURACY OR PRECISION CRITERIA AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE IS NO INDICATION THAT THE LFS PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3357161

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR