BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3062365 · Received April 16, 2013

    Report

    Report Number
    3008382007-2013-08042
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 19, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (08/15/2013)-PRODUCT EVALUATION: THE ANALYSIS OF THE SUBJECT METER WAS COMPLETED ON 08/08/2013 BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE REPORTED COMPLAINT COULD NOT BE REPRODUCED. THE METER MET SPECIFICATIONS FOR TESTING. NO ISSUES WERE IDENTIFIED 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.

    Additional Manufacturer Narrative · 1

    THE LFS PRODUCT(S) HAS BEEN REQUESTED FOR RETURN TO LIFESCAN FOR EVALUATION. IF THE SUBJECT PRODUCT IS RETURNED, AN EVALUATION WILL BE COMPLETED AND THE FINDINGS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN CANADA, ALLEGING INACCURATE RESULTS COMPARED TO THE SAME METER WITH READINGS THAT WERE "1 TO 2.5 MMOL/L" DIFFERENT. THE REPORTER DID NOT PROVIDE THE SPECIFIC READINGS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN'S ACCURACY/PRECISION CRITERIA AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. 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
    163469 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3386298

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR