BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3141419 · Received June 3, 2013

    Report

    Report Number
    3008382007-2013-14113
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 8, 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 # 2 (07/11/2013)-DEVICE EVALUATION: THE SUBJECT METER WAS RETURNED ON 06/03/2013 AND ANALYSIS COMPLETED ON 07/09/2013 BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE REPORTED ISSUE COULD NOT BE REPRODUCED DURING INVESTIGATION. THE METER FUNCTIONED NORMALLY AND NO ISSUES WERE FOUND THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. 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 HAS REQUESTED THE SUBJECT PRODUCTS TO BE RETURNED FOR EVALUATION HOWEVER, THE PRODUCTS HAVE NOT YET BEEN RETURNED OR EVALUATED. IF LIFESCAN RECEIVES THE PRODUCT LIFESCAN WILL INFORM THE FDA OF ANY PRODUCTS THAT FAIL EVALUATION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (6/21/2013). THE PATIENT¿S TEST STRIPS HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 5/24/2013 AND 6/11/2013, RESPECTIVELY, WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT PASSED TESTING. THE TEST STRIPS WERE EVALUATED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED; HOWEVER, A SECONDARY ISSUE WAS NOTED WHERE ERROR 4 WAS OBSERVED DURING CONTROL SOLUTION TESTS. THE METER HAS ALSO BEEN RETURNED TO LFS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.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 REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING INACCURATE RESULTS. THE REPORTER ALLEGED RESULTS OF 7.7 MMOL/L ON THE SUBJECT METER AND 4.9 MMOL/L ON THE LABORATORY METER. 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
    245411 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3352093

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR