BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 5925144 · Received September 2, 2016

    Report

    Report Number
    1823260-2016-01305
    Event Type
    Malfunction
    Date Received
    September 2, 2016
    Date of Event
    August 9, 2016
    Report Date
    September 14, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE ISSUE WAS THE DEFECTIVE VALVE BLOCK USED FOR THE INTERNAL WASHING OF SAMPLE PROBES AND THE ISE SYRINGE. A VALVE THAT DOES NOT OPEN PROPERLY COULD CAUSE DECREASED INTERNAL WASHING EVENTUALLY LEADING TO CARRY OVER ISSUES AND CONTAMINATION OF THE PROBES. THE CUSTOMER HAS CONFIRMED THEY HAVE NOT HAD ADDITIONAL ISSUES SINCE THE FSR REPLACED THE VALVE.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF AN ISSUE THAT BEGAN WHEN THE SAMPLE PROBE ON THE INSTRUMENT WENT INTO THE SAMPLE TUBE GEL. THE CUSTOMER PUT ON A NEW SAMPLE PROBE AND PERFORMED AN AIR PURGE, PROBE CHECK AND MECHANISM CHECK TIMES 10. AFTER THIS, CALCIUM GEN.2 (CA2), TP AND AST TESTS PRODUCED ERRORS. THE CUSTOMER PROVIDED DATA FOR 5 PATIENTS TESTED FOR CA2. BASED ON THE DATA PROVIDED, THE RESULTS FOR 4 PATIENTS WERE ERRONEOUS AND REPORTED OUTSIDE OF THE LABORATORY. THE ISSUE WITH THE CA2 RESULTS OCCURRED AFTER THE CUSTOMER CHANGED THE SAMPLE PROBE. PATIENT 1 INITIAL CA2 RESULT WAS 7.7 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON A DIFFERENT INSTRUMENT ON (B)(6) 2016 AND THE RESULT WAS 9.8 MG/DL. THIS RESULT WAS CONSIDERED TO BE CORRECT AND WAS REPORTED OUTSIDE OF THE LABORATORY. PATIENT 2 INITIAL CA2 RESULT WAS 7.0 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON A DIFFERENT INSTRUMENT ON (B)(6) 2016 AND THE RESULT WAS 9.4 MG/DL. THIS RESULT WAS CONSIDERED TO BE CORRECT AND WAS REPORTED OUTSIDE OF THE LABORATORY. PATIENT 3 INITIAL CA2 RESULT WAS 7.3 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON A DIFFERENT INSTRUMENT ON (B)(6) 2016 AND THE RESULT WAS 9.0 MG/DL. THIS RESULT WAS CONSIDERED TO BE CORRECT AND WAS REPORTED OUTSIDE OF THE LABORATORY. PATIENT 4 INITIAL CA2 RESULT WAS 7.4 MG/DL. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON A DIFFERENT INSTRUMENT ON (B)(6) 2016 AND THE RESULT WAS 8.9 MG/DL. THIS RESULT WAS CONSIDERED TO BE CORRECT AND WAS REPORTED OUTSIDE OF THE LABORATORY. NO ADVERSE EVENT OCCURRED. THE CA2 REAGENT LOT NUMBER WAS 152966-01 WITH AN EXPIRATION DATE OF 08/31/2017. THE FIELD SERVICE REPRESENTATIVE (FSR) IDENTIFIED NUMEROUS CALIBRATION ERRORS AND QUALITY CONTROL (QC) PROBLEMS. A VALVE WHICH SUPPLIES WATER TO A PROBE WAS NOT OPENING PROPERLY TO ALLOW WATER TO FLOW THROUGH IT. THE COMPLETE VALVE BLOCK WAS REPLACED. THE WASH WATER PRESSURE WAS ADJUSTED AND CONFIRMED TO BE WITHIN SPECIFICATION. INSTRUMENT CHECKS WERE PERFORMED AND WERE ACCEPTABLE. THE CUSTOMER HAS NOT HAD ANY FURTHER ISSUES SINCE THE SERVICE ACTION PERFORMED BY THE FSR. THE ROOT CAUSE OF THE ISSUE IS LIKELY AN INCOMPLETE INTERNAL PROBE WASHING CAUSED BY THE DEFECTIVE VALVE BLOCK IDENTIFIED BY THE FSR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575966 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1