BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 11517510 · Received March 18, 2021

    Report

    Report Number
    1823260-2021-00853
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    March 1, 2021
    Report Date
    May 26, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REVIEW OF THE ALARM TRACE, ABNORMAL ASPIRATION ERRORS AND A SAMPLE SHORT ERROR OCCURRED. THESE ERRORS INDICATE A POSSIBLE ISSUE WITH SAMPLE QUALITY. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    MEDWATCH FIELD UDI NUMBER = (B)(4).

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH IGM-2 TINA-QUANT IGM GEN.2 ON A COBAS 6000 C (501) MODULE (SERIAL NUMBER (B)(4)) AND A SECOND C501 SYSTEM AT ANOTHER SITE (UNKNOWN SERIAL NUMBER). NO ALLEGED ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO UNITS OF MEASURE WERE PROVIDED. THE SAMPLE INITIALLY RESULTED IN AN IGM VALUE OF < 5 AND REPEATED AS 19 WHEN TESTED ON THE CUSTOMER'S C501 ANALYZER. THE SAMPLE WAS SENT TO ANOTHER SITE FOR TESTING ON A SECOND C501 ANALYZER AND THE RESULTS WERE SIMILAR. NO SPECIFIC VALUES COULD BE PROVIDED FROM THE OTHER SITE. THE IGM REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415683 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1