BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT HEMOGLOBIN A1C GEN.2

    MDR report key: 2081132 · Received May 9, 2011

    Report

    Report Number
    1823260-2011-02460
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 19, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LCP
    PMA / PMN Number
    K072714
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. RETENTION SAMPLE TESTING WAS PERFORMED AND WITHIN SPECIFICATION. NO REAGENT ISSUE WAS IDENTIFIED. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE HEMOGLOBIN A1C RESULTS FOR THREE PATIENT SAMPLES FROM THE COBAS C501 ANALYZER SERIAL NUMBER (B)(4) THAT WERE LOW WHEN COMPARED TO THE REPEAT RESULTS ON (B)(6) 2011. PATIENT SAMPLE 1 INITIAL RESULT WAS 22.3 % AND THE REPEAT RESULT WAS 7.7 %. PATIENT SAMPLE 2 WAS FROM A MALE BORN ON (B)(6). THE INITIAL RESULT WAS 28.3 % AND THE REPEAT RESULT WAS 8.2 %. PATIENT SAMPLE 3 WAS FROM A MALE BORN (B)(6). THE INITIAL RESULT WAS 14.4 % AND THE REPEAT RESULT WAS 5.6 %. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENTS WERE NOT ADVERSELY AFFECTED. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE. TO VERIFY THE ANALYZER OPERATION, HE PERFORMED OPERATIONAL CHECKS AND PRECISION CHECKS WITH RESULTS WITHIN SPECIFICATIONS.

    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 63837901

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR