BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2894470 · Received January 3, 2013

    Report

    Report Number
    3008382007-2013-00014
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Report Date
    December 18, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (03/06/2013)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED ON (B)(4) 2013 AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 WITH THE FOLLOWING FINDING: THE TEST STRIP PASSED TESTING WITH NO FAULTS FOUND. IF 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

    THE PATIENT COMPARED THEIR VERIO PRO METER TO ANOTHER VERIO PRO METER. THE PATIENT HAD OBTAINED A 8.9 MMOL/L ON THEIR VERIO METER AND LESS THAN 30 MINUTES LATER OBTAINED A 4.4 MMOL/L ON ANOTHER VERIO PRO METER. THE PATIENT DENIED EXHIBITING ANY SYMPTOMS OR SEEKING ANY MEDICAL ATTENTION DUE TO THE ALLEGED ISSUE. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. A QUALITY CONTROL TEST WAS NOT DONE SINCE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION. THE COMPLAINT IS BEING REPORTED SINCE METER TO ANOTHER METER COMPARISON IS GREATER THAN 30 MG/DL OR 30%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3125 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3363355

    Patients

    Seq Age Sex Outcome Treatment
    1