BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1595398 · Received February 5, 2010

    Report

    Report Number
    1823260-2010-00833
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    November 16, 2009
    Report Date
    February 5, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJY
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT KNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER EXPERIENCED AN ISSUE WITH CALCIUM RESULTS FOR PATIENT SERUM SAMPLES. THE USER PROVIDED DATA FOR 37 PATIENT SAMPLES, OF WHICH THE RESULTS FOR 6 WERE DISCREPANT. AFTER THE INITIAL RESULTS WERE GENERATED, THE USER RECALIBRATED THE ASSAY, REPEATED QC AND THEN RAN THE SAME PATIENT SAMPLES WHICH CAME OUT WITH GOOD RESULTS. ALL RESULTS ARE IN MG/DL. SAMPLE 1 INITIAL RESULT WAS 7.2, REPEAT RESULT WAS 9.0. SAMPLE 2 INITIAL RESULT WAS 8.4, REPEAT RESULT WAS 9.2. SAMPLE 3 INITIAL RESULT WAS 9.5, REPEAT RESULT WAS 8.4. SAMPLE 4 INITIAL RESULT WAS 8.9, REPEAT RESULT WAS 7.8. ON (B) (6) 2009, SAMPLE 5 INITIAL RESULT WAS 9.4, REPEAT RESULT WAS 7.3. SAMPLE 6 INITIAL RESULT WAS 8.6, REPEAT RESULT WAS 7.4. ALL THE INITIAL PATIENT RESULTS WERE REPORTED. NONE OF THE PATIENTS WERE ADVERSELY AFFECTED. THE CALCIUM REAGENT LOT NUMBER WAS 61867901. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS PROBABLY DUE TO WATER QUALITY. HE REPLACED THE SYRINGE TIPS, RAN SAMPLE AND REAGENT FLOW CHECKS, RAN A CHECK TEST SUCCESSFULLY AND CAPTURED WATER SAMPLES FOR THE LAB TO EVALUATE. HE VERIFIED THE INSTRUMENT PERFORMANCE BY RUNNING PERFORMANCE TESTS AND QC. UPON FOLLOW, THE USER STATED THAT THEY HAVE TESTED THE WATER AND FOUND IT TO HAVE NO CALCIUM AND CURRENTLY BOTH THE ROCHE AND BIORAD CONTROLS ARE IN RANGE. THE FIELD APPLICATION SPECIALIST COULD NOT FIND A PROBLEM. SHE CHECKED THE WASHES AND CALIBRATOR SETPOINT. SHE RAN PRECISION, CONTROLS AND A PATIENT CORRELATION ALL WITH ACCEPTABLE RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1