BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 CORE

    MDR report key: 2943381 · Received February 5, 2013

    Report

    Report Number
    1823260-2013-00668
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 13, 2013
    Report Date
    February 5, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE C-REACTIVE PROTEIN (LATEX) (CRP) RESULT FOR ONE PATIENT ON THEIR COBAS 6000 ANALYZER. THE CUSTOMER STATED THE PATIENT'S SAMPLE WAS TESTED IN A FALSE BOTTOM TUBE DUE TO LOW SAMPLE VOLUME. THE PATIENT'S INITIAL CRP RESULT WAS 1.1 MG/L. IT WAS REPORTED OUTSIDE THE LABORATORY AS <2.0 MG/L. DUE TO THE LOW RESULT, THE PHYSICIAN DISCONTINUED THE PATIENT'S ANTIBIOTIC TREATMENT. THE PHYSICIAN QUESTIONED THE RESULT THE NEXT DAY. ON (B)(6) 2103, THE SAMPLE WAS REPEATED AND THE RESULT WAS 70.3 MG/L. THE PATIENT'S ORIGINAL TUBE WAS RE-CENTRIFUGED AND REPEATED. THE REPEAT RESULT WAS 64.5 MG/L. THE CUSTOMER CONFIRMED THE PATIENT DID NOT RECEIVE ANY ADVERSE EFFECTS FROM HAVING THE ANTIBIOTIC TREATMENT DISCONTINUED. THE CRP REAGENT LOT NUMBER WAS 671162 AND THE EXPIRATION DATE WAS 02/27/2014. THE CUSTOMER STATED THERE WERE NO AIR BUBBLES ON THE SAMPLE. WITH THE INFORMATION PROVIDED BY THE CUSTOMER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48289 COBAS 6000 CORE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 080 YR