BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT HEMOGLOBIN A1C GEN.2

    MDR report key: 2090051 · Received May 16, 2011

    Report

    Report Number
    1823260-2011-02609
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    May 2, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LCP
    PMA / PMN Number
    K072714
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE EVENT COULD NOT BE IDENTIFIED. ONE FALSELY HIGH RESULT WAS RELEASED AND CORRECTED LATER ON. NO ADVERSE EVENTS WERE REPORTED IN THIS CASE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY WERE RECEIVING QUESTIONABLY HIGH RESULTS ON 6-8 PATIENT SAMPLES FOR HBA1C ON THEIR COBAS C501 (SERIAL NUMBER (B)(4)). THE CUSTOMER PROVIDED DATA FOR FOUR QUESTIONABLE PATIENT SAMPLES. OF THAT DATA, ONE RESULT WAS DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. ALL REPEAT TESTING WAS PERFORMED THE SAME DAY ON THE SAME ANALYZER. THE PATIENT'S INITIAL RESULT WAS 17.6%. THE CUSTOMER QUESTIONED THE HIGH RESULT AND PERFORMED QUALITY CONTROL AND DID MAINTENANCE ON THE ANALYZER. THE CUSTOMER THEN RECALIBRATED AND PERFORMED QUALITY CONTROL WITH PASSING RESULTS. THE CUSTOMER REPEATED THE SAMPLE AND THE RESULT WAS 5.8% THAT WAS SENT OUT AS A CORRECTED REPORT. THERE WERE NO ADVERSE AFFECTS TO ANY PATIENTS AS A RESULT OF THIS EVENT. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE THE CAUSE OF THE EVENT. HE REPLACED THE REAGENT CASSETTE, PERFORMED PROBE WASH AND CLEANING AND CHECKED THE PHOTOMETER AND CELL BLANKS. HE RAN PERFORMANCE TESTING WITH PASSING RESULTS. THE CUSTOMER THEN PERFORMED QUALITY CONTROL WITH PASSING RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TINA-QUANT HEMOGLOBIN A1C GEN.2 ASSAY, GLYCOSYLATED HEMOGLOBIN LCP ROCHE DIAGNOSTICS NA 63434401

    Patients

    Seq Age Sex Outcome Treatment
    1