BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAPILLON VISION

    MDR report key: 1879067 · Received October 21, 2010

    Report

    Report Number
    2954323-2010-01462
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Date of Event
    September 29, 2010
    Report Date
    July 14, 2011
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    THE REPORT SOURCE ON FOLLOW-UP #1 SHOULD HAVE REFLECTED HEALTH PROFESSIONAL. THE DATE RECEIVED BY MANUFACTURER ON FOLLOW-UP #1 SHOULD HAVE REFLECTED THE DATE OF (B)(6) 2010. AS PER THE ARRANGEMENTS DISCUSSED WITH THE OFFICE OF SURVEILLANCE AND BIOMETRICS AT FDA, THIS MDR IS BEING SUBMITTED FOR CORRECTION AS EXPLAINED TO THE AGENCY IN A (B)(6) 2011 LETTER ADDRESSED TO (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READINGS THE CUSTOMER REPORTED WERE NOT FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING INACCURATE READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING A READING OF 215 MG/DL COMPARED TO A LAB READING OF 95 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    FAILURE TO PROVIDE ADEQUATE AIAT INFO, INCLUDING AIAT PASSWORD FOR TESTING OF XRAY AND DETECTION SYSTEM, EXPOSED PT TO UNNECESSARY RADIATION PER (B)(6). FAILURE TO PROVIDE INSTRUCTIONS PER (B)(6). DATES OF USE: (B)(6) 2010 - (B)(6) 2010, 60 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAPILLON VISION BLOOD GLUCOSE MONITORING SYSTEM NBW 1052721

    Patients

    Seq Age Sex Outcome Treatment
    1