BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2971380 · Received February 21, 2013

    Report

    Report Number
    1823260-2013-01100
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 31, 2013
    Report Date
    April 26, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LTJ
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE IN QUESTION WAS SUBMITTED FOR FURTHER INVESTIGATION AND THE CUSTOMER'S RESULTS WERE CONFIRMED. ALTHOUGH NO SPECIFIC ROOT CAUSE COULD BE DETERMINED, THE TESTING SHOWED THE EVENT COULD HAVE BEEN DUE TO A RARE PSA ISOFORM PRESENT IN THE SAMPLE, WHICH WAS NOT RECOGNIZED EFFICIENTLY BY THE ANTIBODIES IN THE TOTAL PSA REAGENT. SINCE THE PSA RESULTS FOR ANOTHER METHOD DID NOT SEEM CONCLUSIVE, A PATIENT SAMPLE MATRIX ISSUE COULD ALSO HAVE HAD SOME INTERFERING EFFECTS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TOTAL PSA) RESULTS FOR ONE PATIENT SAMPLE WHEN COMPARED TO THE FREE PSA RESULTS. THE INITIAL TOTAL PSA RESULT WAS 0.15 NG/ML AND THE INITIAL FREE PSA RESULT WAS 0.5 NG/ML. THE REPEAT TOTAL PSA RESULT WAS 0.148 NG/ML AND THE REPEAT FREE PSA RESULT WAS 0.497 NG/ML. THE SAMPLE WAS REPEATED ON A BECKMAN ANALYZER AND THE TOTAL PSA RESULT WAS 0.8 NG/ML WHICH WAS BELIEVED TO BE CORRECT. THE COBAS TOTAL PSA RESULT WAS REPORTED ALONG WITH THE BECKMAN RESULT WITH AN ADVISORY TO THE PHYSICIAN NOT TO RELY ON THE RESULT FROM THE COBAS E601 ANALYZER. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TOTAL PSA REAGENT LOT NUMBER WAS 16644201 WITH AN EXPIRATION DATE OF 03/31/2013. THE CUSTOMER REFUSED A SERVICE VISIT FOR THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76459 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER LTJ ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1