BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3222597 · Received July 12, 2013

    Report

    Report Number
    1823260-2013-04223
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    July 4, 2013
    Report Date
    December 2, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DAP
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE ALSO PERFORMED A CHECK TEST IN ADDITION TO THE PRECISION STUDIES THAT WERE PERFORMED. THE CUSTOMER HAS DECLINED FURTHER TROUBLESHOOTING.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED THE SPECIFIC VALUES FOR THE PATIENT SAMPLE. THE SAMPLE INITIALLY RESULTED AS 589 NG/ML. THE CUSTOMER REPEATED THE SAMPLE SINCE THEY WERE HAVING PROBLEMS WITH PRECISION. THE CUSTOMER STATES THAT THEY ALSO USE THEIR QUALITY CONTROL AS AN INDICATOR THAT THERE MAY BE AN ISSUE. ON (B)(6) 2013, THE CUSTOMER HAD TO REPEAT THE LEVEL 1 CONTROL SINCE IT INITIALLY RECOVERED OUT OF RANGE. THEY POURED A FRESH CUP FOR THE QUALITY CONTROL AND REPEATED IT, RECOVERING WITHIN RANGE. NO PATIENT SAMPLES WERE RUN ON (B)(6) 2013. THE SAMPLE FROM (B)(6) 2013 WAS REPEATED AND IT RESULTED AS 427 NG/ML. THE SAMPLE WAS REPEATED A SECOND TIME RESULTING AS 393 NG/ML. THE FIELD SERVICE REPRESENTATIVE RETURNED TO THE SITE AND COULD NOT DETERMINE A ROOT CAUSE AFTER FURTHER TROUBLESHOOTING. HE REPLACED THE SAMPLE PROBE, REPLACED THE R1 MIXER, AND ADJUSTED ALL OF THE MIXERS. HE ADJUSTED THE REACTION DISK. THE ISSUE WITH D-DIMER IS NOT RESOLVED AND THE CUSTOMER IS NOT CURRENTLY RUNNING THE ASSAY. THE CUSTOMER RAN QUALITY CONTROLS ON ALL OTHER ASSAYS AND ALL WERE WITHIN SPECIFICATIONS. THE FIELD SERVICE REPRESENTATIVE ALSO TRIED A NEW LAMP HOLDER ASSEMBLY WITH NO CHANGE. HE REPLACED THE R1 PROBE WITH NO CHANGE. THE CUSTOMER STATED THAT THEY WILL NOT BE RUNNING D-DIMER ON THIS ANALYZER AND DECLINED FURTHER TROUBLESHOOTING. ALL OTHER ASSAYS ARE RUNNING WITH NO ISSUES. THE FIELD SERVICE REPRESENTATIVE PERFORMED ADDITIONAL PRECISION STUDIES AND THE ASSAYS THAT HE TESTED HAVE GOOD PRECISION. THE CUSTOMER RAN CALIBRATIONS AND QUALITY CONTROLS; ALL WERE WITHIN SPECIFICATIONS. THE FIELD SERVICE REPRESENTATIVE RAN A PRECISION STUDY FOR GLUCOSE AND THIS LOOKED GOOD. HE RAN A PRECISION STUDY FOR D-DIMER AND THIS WAS NOT GOOD. THE D-DIMER PRECISION STUDY WAS RUN WITH AMYLASE AND LIPASE ORDERS SINCE THIS REPLICATED WHAT HAPPENED WITH THE PATIENT SAMPLE.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED AS THE CUSTOMER HAS DECLINED FURTHER TROUBLESHOOTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR TINA-QUANT D-DIMER (D-DIMER). THE SAMPLE INITIALLY RESULTED AS "AROUND 580 NG/ML". THE CUSTOMER REPEATED THE SAMPLE BECAUSE OF ONGOING D-DIMER ISSUES. THE REPEAT RESULTED AS "AROUND 480 NG/ML" AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED A SECOND TIME RESULTING AS "ABOUT 350 NG/ML". THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE D-DIMER REAGENT LOT NUMBER WAS 67480101 WITH AN EXPIRATION DATE OF 03/31/2014, THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. HE CHECKED THE ANALYZER OPERATION AND FLUIDICS; ALL LOOKED GOOD. PRECISION STUDIES WERE RUN ON SEVERAL ASSAYS AND ALL WERE WELL WITHIN SPECIFICATIONS. D- DIMER PRECISION, HOWEVER, WAS FOUND TO BE VERY POOR. THE CUSTOMER MASKED D-DIMER FROM RUNNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322398 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER DAP ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1