BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2925208 · Received January 22, 2013

    Report

    Report Number
    3008382007-2013-01291
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    December 27, 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
    FR
    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

    (B)(4): THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE ERROR COULD NOT BE REPRODUCED. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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- 1/21/2012.METER- 2/11/2013.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER WAS EVALUATED AND NO ERROR MESSAGE WAS OBSERVED DURING CONTROL SOLUTION TESTS. 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) 2012 THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WAS GIVING AN UNSPECIFIED ERROR MESSAGE DURING TESTING. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE. HOWEVER, AS THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING 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
    30042 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3306762

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR