BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 3901437 · Received June 30, 2014

    Report

    Report Number
    1823260-2014-04739
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 30, 2014
    Report Date
    August 13, 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

    CORRECT RESULTS WERE RECEIVED UPON REPEAT TESTING AFTER THE SAMPLES WERE REMIXED, THE INVESTIGATION DETERMINED THE ISSUE WAS CAUSED BY SAMPLE SEDIMENTATION DUE TO EITHER A LONG WAIT ON THE ROTOR BEFORE SAMPLING OR DUE TO FASTER SEDIMENTATION OF SOME SAMPLES DUE TO A PATHOLOGICAL REASON. IT WAS RECOMMEND TO RUN THE SAMPLES IN SMALLER BATCHES AND TO AVOID A LONG WAIT ON THE ROTOR BEFORE PIPETTING. THE PROVIDED CALIBRATION AND QC DATA WAS ACCEPTABLE, A GENERAL ISSUE WITH THE INSTRUMENT OR REAGENT COULD BE EXCLUDED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE TINA-QUANT HEMOGLOBIN A1C GEN.2 (HBA1C) RESULTS FOR TWO PATIENT SAMPLES. PATIENT 1 ORIGINAL RESULT WAS 0.042 AND THE REPEAT RESULT WAS 0.061. PATIENT 2 ORIGINAL RESULT WAS 0.049 AND THE REPEAT RESULT WAS 0.065. NO UNIT OF MEASURE WAS PROVIDED. THE ORIGINAL RESULT WAS REPORTED OUTSIDE THE LAB. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE HBA1C REAGENT LOT NUMBER WAS 69089201. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380069 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1