BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3090663 · Received May 2, 2013

    Report

    Report Number
    3008382007-2013-09915
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Report Date
    April 5, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (6/20/2013) -DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 6/12/2013 WITH THE FOLLOWING FINDINGS: THE METER FAILED TESTING. THERE WAS FOUND TO BE AN OPEN/SHORTED CAPACITOR. 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 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF LIFESCAN OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT IN THE (B)(4) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO IQ METER WOULD NOT POWER ON. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE. AS THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191122 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1