BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3090752 · Received May 2, 2013

    Report

    Report Number
    3008382007-2013-09919
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Report Date
    April 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S PRODUCTS HAVE BEEN RETURNED TO LIFESCAN FOR EVALUATION; HOWEVER, THE EVALUATION PROCESS HAS NOT YET BEEN COMPLETED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (08/09/2013)-PRODUCT EVALUATION: THE SUBJECT METER WAS RETURNED ON 05/01/2013 AND ANALYSIS COMPLETED ON 08/05/2013 BY LIFESCAN PRODUCT ANALYSIS. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE MET ALL SPECIFICATIONS FOR TESTING AND NO ISSUES WERE OBSERVED 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 IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING INACCURATELY HIGH READINGS COMPARED TO ANOTHER METER. THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 6.8 MMOL/L ON THE REPORTED METER AND A READING OF 1.2 MMOL/L ON THE OTHER METER. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE. AS THE ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED. 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
    191900 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR