BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2840373 · Received November 20, 2012

    Report

    Report Number
    1823260-2012-05881
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    November 2, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LTJ
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION. IT WAS DETERMINED THE PATIENT SAMPLE CONTAINED AUTO-ANTIBODIES WHICH INTERFERE WITH THE TPSA ASSAY.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FROM ONE PATIENT SAMPLE TESTED FOR TOTAL (FREE + COMPLEXED) PROSTATE-SPECIFIC ANTIGEN (TPSA) AND FREE PSA (FPSA). THE SAMPLE INITIALLY RESULTED AS 0.121 UG/L FOR TPSA AND 4.90 UG/L FOR FPSA. THE SAMPLE WAS AUTOMATICALLY REPEATED BY THE ANALYZER, RESULTING AS 0.114 UG/L FOR TPSA AND 4.97 UG/L FOR FPSA. IT IS NOT KNOWN IF ANY OF THESE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. IT IS NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED BY THE EVENT. NO ADVERSE EVENTS WERE ALLEGED. THE FPSA REAGENT LOT NUMBER WAS 168496, NO EXPIRATION DATE WAS PROVIDED. THE TPSA REAGENT LOT NUMBER WAS 169526, NO EXPIRATION DATE WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 077 YR FINASTERAX| XATRAL| SORTIS| CONCOR| MARCOUMAR| ASPIRIN CARDIO 100MG| LASIX