BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 3904691 · Received July 1, 2014

    Report

    Report Number
    1823260-2014-04779
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 8, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE COBAS C501 ANALYZER B.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE TOTAL PROTEIN GEN. 2 RESULTS FOR AN ESTIMATED 250 PATIENT SAMPLES THAT WERE UP TO 20 G/L HIGHER WHEN TESTED IN COMBINATION WITH THE BCP ALBUMIN ASSAY THAN WHEN THE TOTAL PROTEIN WAS RUN ALONE. THIS ISSUE BEGAN WHEN THE CUSTOMER BEGAN USING THE BCP ALBUMIN ASSAY ON (B)(6) 2014. THIS CUSTOMER HAS MULTIPLE C501 MODULES AND SAW THIS ISSUE ON ALL MODULES. DATA WAS PROVIDED FOR TWO COBAS C501 ANALYZERS. OF THE DATA FOR SEVEN PATIENT SAMPLES, ONLY THE RESULTS FOR SIX WERE DISCREPANT. THE SPECIFIC DATE OF TESTING WAS NOT PROVIDED. SAMPLE 1: RESULTS WHEN TOTAL PROTEIN WAS RUN ALONE: 84 G/L. RESULT FROM VITROS ANALYZER: 85 G/L. RESULT FROM COBAS C501 A WHEN TESTED IN COMBINATION WITH BCP ALBUMIN: 93 G/L. RESULT FROM COBAS C501 B WHEN TESTED IN COMBINATION WITH BCP ALBUMIN: 105 G/L. SAMPLE 2: RESULTS WHEN TOTAL PROTEIN WAS RUN ALONE: 72 G/L. RESULT FROM VITROS ANALYZER: 73 G/L. RESULT FROM COBAS C501 A WHEN TESTED IN COMBINATION WITH BCP ALBUMIN: 82 G/L. RESULT FROM COBAS C501 B WHEN TESTED IN COMBINATION WITH BCP ALBUMIN: 89 G/L. SAMPLE 3: RESULTS WHEN TOTAL PROTEIN WAS RUN ALONE: 66 G/L. RESULT FROM VITROS ANALYZER: 69 G/L. RESULT FROM COBAS C501 A WHEN TESTED IN COMBINATION WITH BCP ALBUMIN: 77 G/L. RESULT FROM COBAS C501 B WHEN TESTED IN COMBINATION WITH BCP ALBUMIN:86 G/L. SAMPLE 4: RESULTS WHEN TOTAL PROTEIN WAS RUN ALONE: 56 G/L. RESULT FROM VITROS ANALYZER: 56 G/L. RESULT FROM COBAS C501 A WHEN TESTED IN COMBINATION WITH BCP ALBUMIN: 67 G/L. RESULT FROM COBAS C501 B WHEN TESTED IN COMBINATION WITH BCP ALBUMIN: 77 G/L. SAMPLE 5: RESULTS WHEN TOTAL PROTEIN WAS RUN ALONE: 59 G/L. RESULT FROM VITROS ANALYZER: 60 G/L. RESULT FROM COBAS C501 A WHEN TESTED IN COMBINATION WITH BCP ALBUMIN: 69 G/L. RESULT FROM COBAS C501 B WHEN TESTED IN COMBINATION WITH BCP ALBUMIN: 78 G/L. SAMPLE 6: RESULTS WHEN TOTAL PROTEIN WAS RUN ALONE: 62 G/L. RESULT FROM VITROS ANALYZER: 63 G/L. RESULT FROM COBAS C501 A WHEN TESTED IN COMBINATION WITH BCP ALBUMIN: 71 G/L. RESULT FROM COBAS C501 B WHEN TESTED IN COMBINATION WITH BCP ALBUMIN: 81 G/L. NUMEROUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. SPECIFIC INFORMATION CONCERNING WHICH RESULTS WERE REPORTED WAS NOT PROVIDED. THERE WAS NO ADVERSE EVENT. THE TOTAL PROTEIN REAGENT LOT NUMBER WAS 696847 WITH AN EXPIRATION DATE OF 05/29/2015. THE FIELD SERVICE REPRESENTATIVE CHANGED THE R2 PROBE ON ALL MODULES AND THE PROBLEM WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383258 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1