BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2182394 · Received July 28, 2011

    Report

    Report Number
    3008382007-2011-00092
    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 HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(6), 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. THE METER AND TEST STRIP VIAL WERE TESTED AND NO FAULTS WERE FOUND. 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 INACCURATELY HIGH READINGS. IT IS NOT CLEAR IF THE COMPARISON WAS MADE TO ANOTHER METER OR TO A LABORATORY METHOD, AS CUSTOMER SERVICE DOCUMENTED BOTH. THE PATIENT OBTAINED THE BLOOD GLUCOSE READINGS OF 158 MG/DL, 175 MG/DL, 232 MG/DL, 178 MG/DL, 181 MG/DL, 338 MG/DL, ON THE REPORTED METER AND LABORATORY RESULTS OF, 139 MG/DL, 141 MG/DL, 207 MG/DL, 147 MG/DL, 166 MG/DL, 299 MG/DL WITHIN AN UNSPECIFIED TIME PERIOD. NO INFORMATION WAS PROVIDED ABOUT THE TEST STRIPS OR TESTING TECHNIQUE. THE PATIENT DID NOT REPORT ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION. THE PATIENT DID NOT SUFFER ANY INJURY DUE TO THE REPORTED METER. HOWEVER, AS THE TEST RESULTS FELL OUTSIDE EXPECTED VALUES FOR 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

    Patients

    Seq Age Sex Outcome Treatment
    1