BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2181975 · Received July 28, 2011

    Report

    Report Number
    3008382007-2011-00091
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    July 7, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (09/07/2011) - DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON AUGUST 9, 2011 THE TEST STRIPS INVOLVED IN THIS CASE FAILED TESTING. ON PERFORMANCE TESTING WITH CONTROL SOLUTION, THE RESULTS WERE FOUND TO FALL ABOVE THE LABELED RANGE. THEREFORE, THE COMPLAINT IS CONFIRMED. ON AUGUST 18, 2011 THE METER WAS TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED, HOWEVER, A SECONDARY ISSUE WAS NOTED, THE METER WAS FOUND TO HAVE PCB CONTAMINATION. 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

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN (LFS) TO REPORT THE ONE TOUCH VERIOPRO METER WAS GIVING INACCURATE READINGS. THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF 221 MG/DL ON THE REPORTED METER, AND A RESULT OF 150 MG/DL ON ANOTHER METER WITHIN 30 MINUTES. THE PATIENT'S TESTING TECHNIQUE WAS CORRECT AND THE TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING. THE PATIENT REPORTED NO SYMPTOMS OR MEDICAL ATTENTION. THE PATIENT DID NOT SUFFER ANY INJURY DUE TO THE REPORTED PRODUCT. HOWEVER, AS THE TEST RESULTS FELL OUTSIDE EXPECTED VALUES FOR METER-TO-METER ACCURACY TESTING, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3123230

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR