BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 4122273 · Received September 26, 2014

    Report

    Report Number
    1823260-2014-07358
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 10, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE QUALITY CONTROL WAS WITHIN SPECIFICATIONS. THE CALIBRATION TRACE SHOWED LOWER SIGNALS THAN EXPECTED. FROM (B)(4) 2014 UNTIL (B)(4) 2014, THERE WERE MULTIPLE SAMPLING ALARMS, POINTING TO POOR SAMPLE QUALITY. THE CUSTOMER STATED IT WAS UNLIKELY THERE WERE FOAM OR BUBBLES ON THE REAGENT SURFACE FOR THESE EVENTS. A GENERAL REAGENT OR INSTRUMENT ISSUE SEEMED UNLIKELY, BUT THE HARDWARE ISSUES OBSERVED BY THE FIELD SERVICE REPRESENTATIVE MIGHT HAVE CONTRIBUTED. IT WAS NOTED THE CUSTOMER WAS NOT USING THE RECOMMENDED RACK ADAPTORS.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCGB) RESULTS ON THEIR E601 ANALYZER. THE CUSTOMER STATED IT WAS AN ONGOING ISSUE AND PROVIDED DATA FOR THREE PATIENTS WITH DISCREPANT RESULTS. THE FIRST PATIENT'S SAMPLE WAS TESTED IN A POUR-OFF CUP AND THE HCGB RESULT WAS 0.1 MIU/ML AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE RESULT DID NOT MEET THE PATIENT'S CLINICAL PICTURE. THE PATIENT'S RESULT WAS NOT CORRECTED UNTIL (B)(6) 2014 WHEN THE SAMPLE WAS PULLED AND REPEATED AFTER THE INITIAL CONTACT FROM THE ER. THE REPEAT RESULT WAS >10000 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED AND THE RESULT WAS 147366 MIU/ML. THE SECOND PATIENT WAS A 35 YEAR OLD FEMALE. ON (B)(6) 2014, THE PATIENT'S INITIAL HCGB RESULT FROM A POUR-OFF CUP WAS 0.1 MIU/ML AND IT WAS REPORTED OUTSIDE THE LABORATORY. A SECOND POUR-OFF FROM THE SAMPLE WAS ORDERED WITH A 1:100 DILUTION RIGHT BEHIND THE FIRST POUR-OFF SAMPLE AND THE RESULT WAS AROUND 150000 MIU/ML. THIS WAS REPEATED TO "CONFIRM A SECOND TIME WITH SIMILAR RESULTS TO THE 150,000 MIU/ML". THE RESULT WAS CORRECTED WITH A MINIMAL TIME DIFFERENCE TO THE ORIGINAL REPORT. THE CUSTOMER DETERMINED THE SAMPLES FROM THE FIRST TWO PATIENTS WERE RUN IN SMALL TUBES LEANING WITHIN THE RACKS AND WERE TESTED WITHOUT THE RECOMMENDED RACK ADAPTORS. THE THIRD PATIENT WAS A 29 YEAR OLD FEMALE. ON (B)(6) 2014, THE PATIENT'S SAMPLE WAS POURED INTO A SAMPLE CUP WITH A 1:100 DILUTION ORDERED AND THE INITIAL RESULT WAS 157.4 MIU/ML. AN UNDILUTED SAMPLE PRODUCED A RESULT OF >1000 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS AUTODILUTED AND THE RESULT WAS 50632 MIU/ML. THE CUSTOMER REPEATED THE PATIENT'S SAMPLE WITH A NEW POUR OFF INTO A SAMPLE CUP AND THE RESULT WAS >10000 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS AUTODILUTED AND THE RESULT WAS 54108 MIU/ML. THE SAMPLE WAS DILUTED 1:100 AND THE RESULT WAS 54070 MIU/ML. THE RESULT OF 54108 MIU/ML WAS CONSIDERED CORRECT AND REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER STATED THE DISCREPANT RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE RESULTS ABOVE 50000 MIU/ML FOR ALL THREE PATIENTS WERE CONSIDERED CORRECT. THERE WERE NO ADVERSE EVENTS. THE HCGB REAGENT LOT NUMBER WAS 17509805 AND THE EXPIRATION DATE WAS 03/31/2015. THE FIELD SERVICE REPRESENTATIVE COULD NOT DUPLICATE THE ISSUE. HE RAN PERFORMANCE TESTING AND ALL THE RESULTS FOR HCGB WERE GOOD. THE SAMPLE PROBE ASSEMBLY DID SHOW SIGNS OF BEING WORN. HE CHECKED THE SAMPLE PROBE ALIGNMENTS AND THEY WERE ACCEPTABLE. ALL THE SYSTEM CHECKS WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600867 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 026 YR