BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 6950879 · Received October 16, 2017

    Report

    Report Number
    1823260-2017-02312
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Date of Event
    August 23, 2017
    Report Date
    December 12, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJW
    PMA / PMN Number
    K033009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE SAMPLE HAD HIGH IGM, IT COULD NOT BE EXCLUDED THAT A MONOCLONAL GAMMOPATHY IS THE ROOT CAUSE FOR THE CUSTOMER'S ISSUE. ACCORDING TO PRODUCT LABELING, IGM GAMMOPATHY MAY CAUSE UNRELIABLE RESULTS. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. THE FOLLOWING MEDWATCH FIELDS HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR ALB2 ALBUMIN GEN.2 (ALB) ON A COBAS 6000 C (501) MODULE - C501. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE CLINICIANS. THE SAMPLE INITIALLY RESULTED AS < 10 AND REPEATED WITH A RESULT THAT WAS TWICE AS HIGH. THE UNITS OF MEASURED USED FOR THE ALB ASSAY WERE ASKED FOR, BUT NOT PROVIDED. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE ALB REAGENT LOT NUMBER AND EXPIRATION DATE WERE ASKED FOR, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731342 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER CJW ROCHE DIAGNOSTICS C501 NA
    731343 ALB2 ALBUMIN GEN.2 BROMCRESOL GREEN DYE-BINDING, ALBUMIN CIX ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1