BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2990373 · Received March 5, 2013

    Report

    Report Number
    3008382007-2013-04263
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 14, 2013
    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
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: PRODUCT ANALYSIS WAS PERFORMED ON THE RETURNED METER ON (B)(4) 2013 WITH FAILING RESULTS. THE PATIENT REPORTED AN UNSPECIFIED ERROR MESSAGE ON THE METER AND A REVIEW OF THE METER LOG SHOWED AN ERROR 4 HAD OCCURRED; HOWEVER NO ERROR MESSAGE WAS REPRODUCED DURING TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: PRODUCT ANALYSIS WAS PERFORMED ON THE RETURNED METER ON (B)(4) 2013 WITH FAILING RESULTS. THE PATIENT REPORTED AN UNSPECIFIED ERROR MESSAGE ON THE METER AND A REVIEW OF THE METER LOG SHOWED AN ERROR 4 HAD OCCURRED; HOWEVER NO ERROR MESSAGE WAS REPRODUCED DURING TESTING. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93404 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3205321

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR