BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 3122402 · Received May 21, 2013

    Report

    Report Number
    1823260-2013-03083
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS FOR NINE PATIENT SAMPLES. OF THE DATA PROVIDED, ONLY THE TOTAL PROTEIN RESULT FOR ONE PATIENT SAMPLE WAS DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE INITIAL RESULT FROM THE SAMPLE PROCESSED BY THE MODULAR PREANALYTIC ANALYZER (MPA) WAS 0.0 G/DL AND WAS REPORTED OUT. THE SAMPLE WAS REPEATED ON (B)(6) 2013 ON THE OTHER COBAS C501 ANALYZER AT THE SITE AND THE RESULT WAS 6.7 G/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE CUSTOMER STATED THEY DID NOT THINK THE PATIENT WAS TREATED OR THERE WERE ANY ADVERSE EVENTS. THE PATIENT WAS DISCHARGED. THE TOTAL PROTEIN REAGENT LOT NUMBER WAS 67544701 WITH AN EXPIRATION DATE OF 04/30/2014. THE CUSTOMER REFUSED A SERVICE VISIT AND STATED THE ISSUE CORRECTED ITSELF WHEN THEY PERFORMED A SYSTEM RESET AND RESTARTED THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223577 COBAS 6000 CORE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1