BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1650304 · Received April 5, 2010

    Report

    Report Number
    1823260-2010-02010
    Event Type
    Malfunction
    Date Received
    April 5, 2010
    Date of Event
    March 15, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CUSTOMER RECEIVED FREE PSA RESULT WHICH WAS HIGHER THAN TOTAL PSA RESULT FOR ONE MALE PATIENT WHO HAD SURGERY IN 2008 FOR PROSTATIC ADENOME. ADDITIONAL INFORMATION RECEIVED: RESULTS FROM SIEMENS REAGENT ON CENTAUR ANALYZER WERE PROVIDED. FIRST SAMPLE GAVE TOTAL PSA RESULT 5.94 AND FREE PSA RESULT 5.61 NG/ML. SECOND SAMPLE GAVE TOTAL PSA RESULT 5.64 NG/ML AND FREE PSA RESULT 4.86 NG/ML. INVESTIGATION IS ON-GOING.

    Additional Manufacturer Narrative · 1

    TWO SAMPLES FROM THE PATIENT WERE INVESTIGATED. MINOR INTERFERENCE TO THE RUTHENIUM ANTIBODY IN THE ELECSYS FREEPSA ASSAY WAS DETECTED. SINCE THE SAME RU-ANTIBODY IS USED IN THE TOTAL PSA ASSAY, THE SAME INTERFERENT MAY BE EXPECTED THERE AS WELL. IN ADDITION, A POSSIBLE REASON FOR THE INCORRECT TOTAL PSA RESULTS IS A RARE ISOFORM OF PSA OR AUTO-ANTIBODIES BLOCKING THE SPECIFIC EPITOPES OF PSA.THE NATURE OF THE INTERFERENCES IN THE PATIENT SAMPLES IS COMPLEX AND APPEARS TO AFFECT COMPETITOR METHODS AS WELL. THE PACKAGE INSERT ADDRESSES INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES INCLUDING HAMA, STREPTAVIDIN OR RUTHENIUM. THERE WAS NO MEDICAL TREATMENT OF THIS PATIENT BASED ON THE DISCREPANT RESULTS.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED TOTAL PSA RESULT WHICH WAS HIGHER THAN FREE PSA RESULT FOR ONE MALE PATIENT WHO HAD SURGERY IN 2008 FOR PROSTATIC ADENOME. TOTAL PSA RESULT WAS 0.666 NG/ML AND FREE PSA RESULT WAS 12.60 NG/ML. THESE RESULTS WERE REPEATED USING A DIFFERENT SAMPLE AT ANOTHER LABORATORY WORKING WITH AN E170 ANALYZER, TOTAL PSA WAS 0.630 NG/ML AND FREE PSA WAS 11.79 NG/ML. THERE WAS NO MEDICAL TREATMENT FOR THIS PATIENT BASED ON THE DISCREPANT RESULTS. TOTAL PSA REAGENT LOT WAS 155708. FREE PSA REAGENT LOT WAS 155066. INVESTIGATION IS ON-GOING.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 91 MG/DL AND 45 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER STATED THAT SHE HAD SOME HYPOGLYCEMIC SYMPTOMS AND SELF-TREATED WITH FOOD AND DRINK. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    A PATIENT WAS ADMITTED TO THE ER WITH A SUSPECTED CARDIAC EVENT AND TROPONIN T TESTS WERE RUN SEVERAL TIMES WITH A STABLE RESULT AROUND 50 NG/L. THE NEXT DAY, (B) (6) 2010, THE TROPONIN T RESULT FROM A NEW SAMPLE WAS 393 NG/L AND WAS REPORTED TO THE WARD. THE NEXT DAY, (B) (6) 2010, THE WARD CALLED BACK TO THE LAB AND QUESTIONED THE RESULT. A NEW SAMPLE WAS DRAWN AND ANALYZED WITH A RESULT AROUND 50 NG/L. THE SAMPLE WHICH INITIALLY RECOVERED 393 NG/L WAS ANALYZED AGAIN WITH A NEW LOT NUMBER OF REAGENT AND RECOVERED AROUND 50 NG/L. THE PATIENT WAS GIVEN 500 IU FRAGMIN AS A CONSEQUENCE OF THE FALSE POSITIVE RESULT. NO OTHER TREATMENT OR MEDICATION WAS CHANGED AND THE PATIENT DID NOT COME TO ANY HARM. THE TROPONIN T REAGENT LOT NUMBER AT THE TIE OF THE INITIAL RESULT WAS 153401. THE REAGENT LOT AT THE TIME OF THE REPEAT RESULT WAS 154101.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 082 YR