BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3904445 · Received July 1, 2014

    Report

    Report Number
    1823260-2014-04773
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 9, 2014
    Report Date
    August 13, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. REFERENCE THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR ADDITIONAL DATA RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS VERIFIED THAT THEY HAVE HAD NO FURTHER ISSUES RELATED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR TROPONIN T STAT (SHORT TURN AROUND TIME). THIS MEDWATCH IS FOR RESULTS OBTAINED ON E601 ANALYZER SERIAL NUMBER (B)(4). TWO TUBES WERE DRAWN FROM THE SAME PATIENT AT THE SAME TIME AND TESTED SEPARATELY ON TWO DIFFERENT E601 ANALYZERS. THE FIRST TUBE WAS TESTED ON E601 SERIAL NUMBER (B)(4) AND RESULTED AS 0.014 NG/ML. THE SECOND TUBE WAS TESTED ON E601 SERIAL NUMBER (B)(4) AND RESULTED AS 0.023 NG/ML. BOTH THE 0.014 NG/ML AND 0.023 NG/ML VALUES WERE REPORTED OUTSIDE OF THE LABORATORY. THE NURSE QUESTIONED WHICH RESULT WAS CORRECT, SO THE CUSTOMER PULLED BOTH SAMPLES AND REPEATED EACH TUBE ON THE SAME ANALYZER. THE FIRST TUBE WAS REPEATED ON E601 SERIAL NUMBER (B)(4) AND RESULTED AS 0.014 NG/ML. THE SECOND TUBE WAS REPEATED ON E601 SERIAL NUMBER (B)(4) AND RESULTED AS 0.024 NG/ML. THE RESULTS FROM E601 SERIAL NUMBER (B)(4) WERE BELIEVED TO BE CORRECT AFTER THE CUSTOMER REVIEWED THE QUALITY CONTROL RECOVERY AND RAN ROCHE MANUFACTURED CONTROLS. THE INITIAL 0.023 NG/ML VALUE REMAINED ON THE PATIENT RECORD AND THE INITIAL 0.014 NG/ML VALUE WAS REMOVED FROM THE PATIENT RECORD. ONE OF THE TWO TUBES FROM THE PATIENT WAS TESTED ON E601 ANALYZER SERIAL NUMBER (B)(4) AND RESULTED AS 0.013 NG/ML. THE CUSTOMER THEN PULLED 10 ADDITIONAL PATIENT SAMPLES THAT HAD INITIALLY BEEN TESTED ON E601 ANALYZER SERIAL NUMBER (B)(4) AND REPEATED THESE ON E601 ANALYZER SERIAL NUMBER (B)(4). OF THE 10 SAMPLES, 8 WERE FOUND TO HAVE ERRONEOUS RESULTS. IT WAS ASKED, BUT IT IS NOT KNOWN WHEN THESE SAMPLES WERE INITIALLY TESTED. THE INITIAL RESULTS WERE ALL REPORTED OUTSIDE OF THE LABORATORY. THE REPEATS PERFORMED ON E601 ANALYZER SERIAL NUMBER (B)(4) WERE RUN ON (B)(4) 2014. THE CUSTOMER DID NOT CORRECT ANY OF THE INITIAL RESULTS SINCE THE REPEATED RESULTS ALL PRESENTED THE SAME CLINICAL PICTURE. ADDITIONAL SAMPLE ONE INITIALLY RESULTED AS 0.03 NG/ML AND REPEATED AS 0.050 NG/ML. ADDITIONAL SAMPLE TWO INITIALLY RESULTED AS 0.02 NG/ML AND REPEATED AS 0.031 NG/ML. ADDITIONAL SAMPLE THREE INITIALLY RESULTED AS 0.01 NG/ML AND REPEATED AS 0.021 NG/ML. ADDITIONAL SAMPLE FOUR INITIALLY RESULTED AS 0.03 NG/ML AND REPEATED AS 0.053 NG/ML. ADDITIONAL SAMPLE FIVE INITIALLY RESULTED AS 0.01 NG/ML AND REPEATED AS 0.024 NG/ML. ADDITIONAL SAMPLE SIX INITIALLY RESULTED AS 0.04 NG/ML AND REPEATED AS 0.053 NG/ML. ADDITIONAL SAMPLE SEVEN INITIALLY RESULTED AS 1.83 NG/ML AND REPEATED AS 2.22 NG/ML. ADDITIONAL SAMPLE EIGHT INITIALLY RESULTED AS 1.15 NG/ML AND REPEATED AS 1.41 NG/ML. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE TROPONIN T STAT REAGENT LOT NUMBER WAS 17575901 WITH AN EXPIRATION DATE OF 02/28/2015. THE CUSTOMER CALIBRATED ALL THREE E601 ANALYZERS AND RAN QUALITY CONTROLS. THE CUSTOMER STATED THAT THE QUALITY CONTROL PERFORMANCE WAS THEN MUCH BETTER. THE CUSTOMER REPEATED THE 10 ADDITIONAL PATIENT SAMPLES AND THESE CORRELATED MUCH BETTER BETWEEN ALL THREE E601 ANALYZERS. THE CUSTOMER WAS ASKED, BUT DID NOT PROVIDE ANY SPECIFIC REPEAT RESULT INFORMATION FOR THE 10 ADDITIONAL PATIENT SAMPLES. THE CUSTOMER STATED THAT THE ISSUE IS NOW RESOLVED AND THAT THE LAST CALIBRATION MAY HAVE BEEN MARGINAL, CAUSING A SHIFT IN THE QUALITY CONTROL AND PATIENT RESULTS. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. THE CUSTOMER RAN CHECKS AFTERWARDS FOR PATIENT AND QUALITY CONTROL COMPARISONS. THE CUSTOMER STATED THAT THEY FELT THAT THE RESULTS FROM THIS ANALYZER WERE CORRECT COMPARED TO THE OTHER TWO AND DID NOT WANT ANY ADDITIONAL TROUBLESHOOTING TO BE PERFORMED. THE CUSTOMER WAS SATISFIED WITH QUALITY CONTROL RECOVERY AND RESULTS FROM THIS ANALYZER AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383956 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1