BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 2801635 · Received October 23, 2012

    Report

    Report Number
    1823260-2012-05332
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 24, 2012
    Report Date
    January 4, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURED IN (B)(6) . (B)(4).

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THERE WAS NO DETECTABLE ERROR IN SAMPLE HANDLING OR ANALYZER OR REAGENT PERFORMANCE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.2 (HBA1C) RESULTS ON THEIR INTEGRA 800 ANALYZERS. THE CUSTOMER STATED THEY REALIZED THEY HAD AN ISSUE BECAUSE SOME DOCTORS HAD REALIZED THEIR DIABETES MELLITUS PATIENTS HAD POOR GLUCOSE MANAGEMENT AND THEIR CLINICAL PICTURES WERE VERY STRANGE. THE CUSTOMER PROVIDED DATA FOR MULTIPLE PATIENTS, OF WHICH FIVE HAD DISCREPANT RESULTS FROM THIS ANALYZER. ALL REPEAT TESTS WERE PERFORMED ON THE SAME DAY USING THE SAME ANALYZER. THE CUSTOMER CONSIDERED THE LOWER RESULTS TO BE INCORRECT. THE FIRST PATIENT'S INITIAL HBA1C RESULT WAS 3.59%. THE REPEAT RESULT WAS 5.13%. THE SECOND PATIENT'S INITIAL HBA1C RESULT WAS 5.34%. THE REPEAT RESULT WAS 7.13%. THE THIRD PATIENT'S INITIAL HBA1C RESULT WAS 5.07%. THE FIRST REPEAT RESULT WAS 6.85%. THE SECOND REPEAT RESULT WAS 6.73%. THE FOURTH PATIENT'S INITIAL HBA1C RESULT WAS 5.81%. THE FIRST REPEAT RESULT WAS 8.68%. THE SECOND REPEAT RESULT WAS 8.25% ON (B)(6) 2012, THE FIFTH PATIENT'S INITIAL HBA1C RESULT WAS 4.34%. THE FIRST REPEAT RESULT WAS 6.69%. THE SECOND REPEAT RESULT WAS 6.76%. THE CUSTOMER DID NOT REPORT ANY HARM TO THE PATIENTS. THE HBA1C REAGENT LOT NUMBER WAS 657768 AND THE EXPIRATION DATE 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