BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1531642 · Received October 27, 2009

    Report

    Report Number
    1823260-2009-07386
    Event Type
    Malfunction
    Date Received
    October 27, 2009
    Date of Event
    September 24, 2009
    Report Date
    February 3, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED MISHANDLING OF THE PROBE DURING REPLACEMENT WAS THE CAUSE OF THE DISCREPANCIES. THE PROBE WAS CHANGED WITHOUT ACCESSING THE SERVICE PROGRAM. WITHOUT A Z-CALIBRATION AFTER CHANGING THE PROBE, THE INSTRUMENT RAN WITH OLD PARAMETERS WHICH LED TO DEFORMATION OF THE PROBE. A SECOND CAUSE WAS THE USAGE OF CLOSED BOTTLES FOR THE HEMOLYZING REAGENT IN THE ISE RACK. THE PROBE HAS NOW BEEN REPLACED USING THE SERVICE PROGRAM. FURTHERMORE CUSTOMER WAS SHOWN HOW TO REPLACE THE PROBE AND DRYERS, AS WELL AS HOW TO CLEAN THE WASH STATIONS AND SAMPLE HOLDER. NO ADVERSE EVENTS IN RELATION TO THE FALSELY LOW RESULT WERE REPORTED.

    Description of Event or Problem · 1

    NA

    Description of Event or Problem · 1

    CUSTOMER STATED A DOCTOR QUESTIONED A HBA1C RESULT THAT HAD BEEN REPORTED. (THIS ANALYZER IS A CLOSED TUBE DEDICATED HBA1C SYSTEM). ON (B) (6) 2009, THEY BEGAN REPEATING RESULTS THAT HAD INITIALLY BEEN RUN (B) (6) 2009 AND (B) (6) 2009. CUSTOMER PROVIDED TWO EXAMPLES, THE FOLLOWING RESULT WAS DISCREPANT: ORIGINAL HBA1C RESULT WAS 5.7, REPEAT ((B) (6) 2009) GAVE 9.0. THE DISCREPANT RESULTS WERE REPORTED, CUSTOMER REFUSED TO PROVIDE ANY PT INFO INCLUDING CURRENT CONDITION, DIAGNOSIS, TREATMENT PERFORMED, ETC. THE ACCOUNT REPEATED 2,240 SAMPLES THAT MAY HAVE BEEN INVOLVED IN THE ISSUE WITH APPROXIMATELY 200-700 CORRECTIONS. THE CUSTOMER DID NOT PROVIDE ANY INFO REGARDING THE 2,240 SAMPLES NOR THE 200-700 CORRECTIONS. THE FIELD SERVICE REP DETERMINED A DEFECTIVE SAMPLE PROBE TO BE THE CAUSE OF THE DISCREPANCIES AND REPLACED THE PROBE. HE PERFORMED A Z CALIBRATION, CLEANED AND LUBRICATED ALL MOVING MECHANISMS AND REPLACED THE DRYERS. HE VERIFIED ANALYZER OPERATION BY PERFORMING CYCLE CUVETTE HANDLING CHECKS AND QC. THE FIELD APPLICATION SPECIALIST ALSO FOUND THE CUSTOMER WAS NOT HANDLING THE HEMOLYZING REAGENT CORRECTLY BY LEAVING THE CAP ON THE BOTTLES. HE ALSO FOUND THEY WERE USING AN INCORRECT PROCEDURE FOR SAMPLE PROBE EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK