BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 3091955 · Received May 3, 2013

    Report

    Report Number
    3008382007-2013-10063
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 8, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (06/13/2013)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. 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.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING AND THE COMPLAINT WAS NOT CONFIRMED. 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

    ON (B)(6) 2013, THE LAY USER/PATIENT IN (B)(4) CONTACTED LIFESCAN (LFS) TO REPORT THE ONE TOUCH VERIO PRO METER WAS GIVING INACCURATE READINGS. THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 93 MG/DL ON THE REPORTED METER AND A LABORATORY RESULT OF 70 MG/DL. THE PATIENT'S TESTING TECHNIQUE WAS CORRECT AND THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE PATIENT DID NOT REPORT EXPERIENCING ANY SYMPTOMS OR MEDICAL ATTENTION. THE PATIENT DID NOT SUFFER ANY INJURY DUE TO THE REPORTED METER. HOWEVER, AS THE TEST RESULTS FELL OUTSIDE EXPECTED VALUES FOR METER TO LAB ACCURACY TESTING 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
    193759 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3363347

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR