BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 3875128 · Received June 16, 2014

    Report

    Report Number
    1823260-2014-04383
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    June 5, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL DATA WERE REQUESTED BUT NOT PROVIDED. THE CALIBRATION AND QUALITY CONTROL PRIOR TO THE EVENT WERE IN RANGE, AND THE QUALITY CONTROL AFTER SWITCHING TO THE NEW REAGENT WERE WITHIN RANGE. A GENERAL ISSUE WITH THE REAGENT COULD BE EXCLUDED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.2 (HBA1C) RESULTS ON THEIR INTEGRA 800 ANALYZER. THE CUSTOMER STATED THEY PUT A NEW REAGENT CASSETTE ON THE ANALYZER AND THE INTERNAL CONTROLS WERE IN RANGE. NINE MINUTES LATER, THE PROBLEM STARTED WHEN THE HBA1C RESULTS WERE LOWER AND IT WAS EVENTUALLY DETECTED BY RUNNING THE MEAN. DURING THE TIME IN QUESTION, ALL SAMPLES HAD HIGHER RESULTS WHEN THEY WERE REPEATED. AFTER THE TIME IN QUESTION, ALL THE RESULTS WERE GOOD. A NEW CASSETTE WAS LATER STARTED AND QUALITY CONTROL WAS GOOD. THE CUSTOMER STATED 43 HBA1C RESULTS HAD TO BE CORRECTED. THE CUSTOMER PROVIDED DATA FOR 107 SAMPLES, OF WHICH THERE FIVE SAMPLES WITH DISCREPANT RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY. THE FIRST PATIENT'S INITIAL HBA1C RESULT WAS 0.047. IT WAS CORRECTED TO 0.065. THE SECOND PATIENT'S INITIAL HBA1C RESULT WAS 0.076. IT WAS CORRECTED TO 0.102. THE THIRD PATIENT'S INITIAL RESULT WAS 0.054. IT WAS CORRECTED TO 0.077. THE FOURTH PATIENT'S INITIAL HBA1C RESULT WAS 0.065. IT WAS CORRECTED TO 0.095. THE FIFTH PATIENT'S INITIAL HBA1C RESULT WAS 0.077. IT WAS CORRECTED TO 0.144. THERE WERE NO DEATHS, INJURIES, ILLNESSES, OR DETERIORATIONS IN HEALTH ASSOCIATED WITH THE ERRONEOUS RESULTS. INFORMATION ON WHETHER THE PATIENTS WERE HARMED BY ANY ACTION TAKEN WAS REQUESTED BUT NOT PROVIDED. THE HBA1C REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352457 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1