BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2945039 · Received February 6, 2013

    Report

    Report Number
    1823260-2013-00690
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 11, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LEH
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. CONTROL AND CALIBRATION DATA AROUND THE DATE OF OCCURRENCE DO NOT INDICATE A GENERAL PERFORMANCE ISSUE. THE WITHIN RUN CONTROL PRECISION WAS FOUND TO BE HIGH COMPARED TO INTERNAL DATA, WHICH INDICATES A POSSIBLE HARDWARE ISSUE. A HARDWARE ISSUE COULD NOT BE CONFIRMED BASED ON LIMITED DATA AVAILABLE FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR VANCOMYCIN. THE SAMPLE INITIALLY RESULTED AS 1.2 UG/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED WITH AN INCREASED SAMPLE VOLUME, RESULTING AS 15.4 UG/ML. THE SAMPLE WAS REPEATED A SECOND TIME AND RESULTED AS 15.7 UG/ML. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE VANCOMYCIN REAGENT LOT NUMBER WAS 66803201 WITH AN EXPIRATION DATE OF 06/30/2013. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE FOR THE ISSUE. HE CLEANED AND INSPECTED THE SAMPLING FLOWPATH. HE EXAMINED THE CUVETTES. HE CHECKED PRECISION AND ACCURACY. THE PRECISON RESULTS WERE WITHIN GUIDELINES. HE PERFORMED DIAGNOSTIC AND MECHANICAL CHECKS. THE CUSTOMER RAN CALIBRATION AND QUALITY CONTROLS WITH PASSING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51014 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER LEH ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1