BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 5068881 · Received September 10, 2015

    Report

    Report Number
    1823260-2015-04130
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    August 26, 2015
    Report Date
    September 10, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF AN ERRONEOUS LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR TROPONIN T HS (HIGH SENSITIVE) TROPONIN T HS. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL TROPONIN T HS RESULT WAS 4 NG/L. THE PATIENT HAD A TROPONIN T HS RESULT OF 2000 NG/L THE DAY BEFORE. THE SAMPLE THAT PRODUCED THE RESULT OF 4 NG/L WAS REPEATED AND THE RESULT WAS "AROUND" 2000 NG/L. NO ADVERSE EVENT OCCURRED. THE TROPONIN T HS REAGENT LOT NUMBER WAS 181799. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE ON 08/27/2015 AND IDENTIFIED A DAMAGED SAMPLE PROBE. THE SAMPLE PROBE WAS REPLACED AND THE SYSTEM WORKED FINE AT THAT TIME. ON (B)(6) 2015 THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS WITH QUALITY CONTROLS. THIS COULD BE CAUSED BY AIR BUBBLES ON THE SAMPLE SURFACE. THE CALIBRATION SIGNALS FROM (B)(6) 2015 WERE ACCEPTABLE; HOWEVER, CALIBRATION WAS OVERDUE BY 5 MONTHS. QUALITY CONTROLS WERE ACCEPTABLE THE DAY OF THE EVENT. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. BASED ON THE AVAILABLE DATA, THE MOST LIKELY ROOT CAUSE OF THE ERRONEOUS PATIENT RESULT IS RELATED TO THE BROKEN CABLE CONNECTOR ON THE SAMPLE PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598489 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1