BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2955647 · Received February 11, 2013

    Report

    Report Number
    3008382007-2013-02687
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 15, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    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

    FOLLOW-UP (3/11/2013)-DEVICE EVALUATION: THE CONTROL SOLUTION AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6) 2013 RESPECTIVELY WITH THE FOLLOWING FINDINGS: BOTH CONTROL SOLUTION AND TEST STRIPS WERE FOUND TO HAVE AN ERROR 4 ISSUE. 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 PRO METER WAS GIVING THE ERROR 4 ERROR MESSAGE WITH A BLOOD SAMPLE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE. 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
    58443 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3387516

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR