BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA-QUANT HEMOGLOBIN A1C GEN.2

    MDR report key: 2142082 · Received June 28, 2011

    Report

    Report Number
    1823260-2011-03490
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LCP
    PMA / PMN Number
    K072714
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE HEMOGLOBIN A1C (HGA1C) RESULTS FROM THE COBAS C501 ANALYZER SERIAL NUMBER (B)(4) THAT WERE DISCOVERED WHEN A DOCTOR CAUGHT THE DISCREPANCIES AND REPORTED THE ISSUE TO THE LABORATORY. OF THE DATA PROVIDED FOR 12 PATIENT SAMPLES, THE RESULTS FOR FIVE PATIENT SAMPLES WERE DISCREPANT. ALL REPEAT TESTING WAS PERFORMED ON (B)(6) 2011. PATIENT SAMPLE 1 INITIAL RESULT WAS 13.6% AND THE REPEAT RESULT WAS 5.8%. ON (B)(6) 2010, PATIENT SAMPLE 2 INITIAL RESULT WAS 13.5% AND THE REPEAT RESULT WAS 6.0%. ON (B)(6) 2010, PATIENT SAMPLE 3 INITIAL RESULT WAS 12.4% AND THE REPEAT RESULT WAS 6.2%. PATIENT SAMPLE 4 INITIAL RESULT WAS 12.8% AND THE REPEAT RESULT WAS 5.8%. PATIENT SAMPLE 5 INITIAL RESULT WAS 11.9% AND THE REPEAT RESULT WAS 5.9%. NO PATIENTS WERE TREATED BASED ON THE ERRONEOUS RESULTS. AMENDED REPORTS WERE GENERATED FOR THE SAMPLES WITH DISCREPANT RESULTS. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE FOUND THE RINSE NOZZLE WAS OVER FILLING THE REACTION CELL AND A WORN DRYER TIP WAS CAUSING A FLUIDIC FAILURE OF THE RINSE. HE ADJUSTED THE RINSE LEVEL AND REPLACED THE DRYER TIPS. TO VERIFY THE ANALYZER OPERATION, HE RAN PRECISION TESTING 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 63434401

    Patients

    Seq Age Sex Outcome Treatment
    1