BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 5783154 · Received July 11, 2016

    Report

    Report Number
    1823260-2016-00888
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    June 30, 2016
    Report Date
    July 22, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION DETERMINED THE ISSUE WAS RESOLVED BY THE RE-CENTERING OF THE SAMPLE PROBE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE C-REACTIVE PROTEIN GEN.3 RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 0.02 (<1) MG/L AND WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AS IT WAS INCONSISTENT AND AN IMPROBABLE RESULT. THE REPEAT RESULTS WERE 280.33 MG/L AND 276.29 MG/L. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 181885. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED. BASED ON THE PROVIDED REACTION DATA, IT WAS SUSPECTED THAT THE PROBE WAS NOT CENTERED. THE PROBE WAS RE-CENTERED. SEVERAL ERRORS WERE NOTED ON THE PROVIDED CALIBRATION DATA INDICATING AGGLUTINATION OF THE LATEX PARTICLES DUE TO IMPROPER MIXING OF THE REAGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436188 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR