BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 7032712 · Received November 15, 2017

    Report

    Report Number
    1823260-2017-02614
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    October 10, 2017
    Report Date
    November 15, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    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

    (B)(4). THE EVENT OCCURRED IN: (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RAN AN EXTERNAL QUALITY CONTROL FOR ELECSYS CYFRA 21-1 (CYFRA), ELECSYS TOTAL PSA IMMUNOASSAY (TPSA), ELECSYS FREE PSA IMMUNOASSAY (FPSA), ELECSYS AFP ASSAY (AFP), AND ELECSYS PROBNP II IMMUNOASSAY (PROBNPII) ON A COBAS 6000 E 601 MODULE. WHEN THE CUSTOMER RECEIVED THEIR EXTERNAL QUALITY ASSESSMENT RESULTS, THEIR RESULTS WERE "DIVIDED BY TWO." THE CUSTOMER RETESTED THE EXTERNAL QUALITY CONTROLS AND ALL PATIENTS¿ SAMPLES FROM (B)(6) 2017. THE RESULTS FOR THE EXTERNAL QUALITY CONTROL WERE NOW ACCEPTABLE, BUT FOR APPROXIMATELY 20 PATIENTS THERE WERE "OBSERVED DIFFERENCES" FROM THE ORIGINAL RESULTS. SPECIFIC REPEAT RESULTS AND DETAILS WERE NOT PROVIDED. THE ORIGINAL TEST RESULTS FROM CYFRA, TPSA, FPSA, AFP, AND PROBNPII ARE INCLUDED IN THE ATTACHMENT TO THIS MEDWATCH. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CYFRA REAGENT LOT WAS 213742. THE TPSA REAGENT LOT WAS 216023. THE FPSA REAGENT LOT WAS 243139. THE AFP REAGENT LOT WAS 267272. THE PROBNPII REAGENT LOT WAS 227748. THE EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED. DISCREPANT LOW RESULTS ARE TYPICALLY CAUSED BY A SAMPLE PIPETTING ISSUE. AS THE ISSUE APPEARS TO HAVE RESOLVED ITSELF AND DID NOT APPEAR AGAIN, A GENERAL ISSUE WITH THE ANALYZER CAN BE EXCLUDED. FURTHER AS THE ISSUE WAS ON ONLY ONE CHANNEL AN ISSUE WITH THE REAGENTS IS UNLIKELY AS WELL. FINALLY, A NOT SUITABLE SAMPLE (LATE CLOTTING, FIBRIN, HIGH PROTEIN CONCENTRATION) COULD CAUSE A TEMPORARY CONTAMINATION OF THE MEASURING CELL, BUT THIS SHOULD NOT GIVE "GOOD" RESULTS FOR THE TIME THE DISCREPANT RESULTS OCCURRED. NO FURTHER ISSUES ARE REPORTED. BASED ON THE AVAILABLE DATA, NO ROOT CAUSE CAN BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814084 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1