BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1919809 · Received December 10, 2010

    Report

    Report Number
    1823260-2010-07357
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 2, 2010
    Report Date
    October 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE D-DIMER REAGENT LOT NUMBER WAS 638689.

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLES WERE RETURNED FOR INVESTIGATION. BASED UPON THE INVESTIGATION PERFORMED AND INFORMATION PROVIDED, THE ROOT CAUSE OF THE EVENT SEEMS TO BE AN IGG INTERFERENCE WITH A SPECIAL SPECIFICITY IN THESE SAMPLES. THIS ISSUE ONLY OCCURRED ON THE INTEGRA ANALYZER. THE REASON ONLY THE INTEGRA WAS AFFECTED MAY BE SPECIFIC ASSAY CHARACTERISTICS, SUCH AS MXIING, PHOTOMETER, OR WAVELENGTH, USED ON THE INTEGRA THAT ARE NOT USED ON OTHER SYSTEMS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS BORN IN THE YEAR (B)(6). THE "ORIGINAL RESULTS" WERE REPORTED OUTSIDE THE LABORATORY.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE TINA-QUANT D-DIMER (D-DIMER) RESULTS FROM THE INTEGRA 800 WHEN COMPARED TO THE STAR EVOLUTION ANALYZER. THE DATA FROM THE STAR EVOLUTION WAS CONSIDERED IN THE NORMAL RANGE AND THE RESULTS FROM THE INTEGRA WERE CONSIDERED "UNHEALTHY". DATA FOR THREE PATIENT SAMPLES WAS PROVIDED. PATIENT SAMPLE 1 RESULTS WERE: D-DIMER <300 NG/ML. D-DIMER (INTERN) 0.22 UG/ML. THIS WAS THE RESULT FROM THE STAR EVOLUTION. D-DIMER "BESTATIGUNGSTEST" (TINA-QUANT) 2230 NG/ML. D-DIMER (INTERN) (TINA-QUANT) 2.23 UG/ML. THIS WAS THE RESULT FROM THE INTEGRA 800. PATIENT SAMPLE 2 RESULTS ON (B)(6) 2010 WERE: D-DIMER <300 NG/ML. D-DIMER (INTERN) 0.22 UG/ML. THIS WAS THE RESULT FROM THE STAR EVOLUTION. D-DIMER "BESTATIGUNGSTEST" (TINA-QUANT) 1970 NG/ML. D-DIMER (INTERN) (TINA-QUANT) 1.97 UG/ML. THIS WAS THE RESULT FROM THE INTEGRA 800. PATIENT SAMPLE 3 RESULTS ON (B)(6) 2010 WERE: D-DIMER <300 NG/ML. D-DIMER (INTERN) 0.22 UG/ML. THIS WAS THE RESULT FROM THE STAR EVOLUTION. D-DIMER "BESTATIGUNGSTEST" (TINA-QUANT) 2820 NG/ML. D-DIMER (INTERN) (TINA-QUANT) 2.82 UG/ML. THIS WAS THE RESULT FROM THE INTEGRA 800. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE. THE D-DIMER REAGENT LOT NUMBER WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR