BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 6379799 · Received March 6, 2017

    Report

    Report Number
    1823260-2017-00464
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    February 13, 2017
    Report Date
    March 6, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY HAD AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR VANC2 VANCOMYCIN (VANC) ON A COBAS 6000 C (501) MODULE - C501. THE SAMPLE INITIALLY RESULTED AS 44.7 UG/ML ACCOMPANIED BY A DATA FLAG AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WAS QUESTIONED BY THE PHARMACIST, SO THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 20.3 UG/ML. THE SAMPLE WAS ALSO REPEATED A SECOND TIME, RESULTING AS 21.2 UG/ML. THE 21.2 UG/ML VALUE WAS BELIEVED TO BE CORRECT AND WAS REPORTED OUTSIDE OF THE LABORATORY AS THE CORRECTED RESULT. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE VANC REAGENT LOT NUMBER WAS 162144. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER COULD NOT DETERMINE A CAUSE FOR THE ISSUE. HE PERFORMED MECHANICAL AND FLUIDICS CHECKS ON THE ANALYZER. RINSING OF CUVETTES WAS OK. PROBE WASHES AND ALIGNMENTS WERE OK. THE GEAR PUMP PRESSURE AND PROBE DRYING WERE OK. HE PERFORMED PRECISION STUDIES AND ALL WERE WITHIN SPECIFICATIONS. THE CUSTOMER'S CONTROLS WERE WITHIN SPECIFICATIONS. THE PROBABLE CAUSE OF THE EVENT WAS RELATED TO PRE-ANALYTIC SAMPLE HANDLING. THE SAMPLE PROBE MAY HAVE BEEN CONTAMINATED WITH GEL OR FIBRIN FROM THE SAMPLE CAUSING A PIPETTING ERROR. ADDITIONAL TESTS PERFORMED ON THE SAMPLE WERE FLAGGED WITH SAMPLE CLOT ERRORS, MEANING THAT A CLOT WAS DETECTED DURING SAMPLE ASPIRATION. CALIBRATION AND CONTROL RECOVERY PRIOR TO AND AFTER THE EVENT WERE WITHIN RANGE, SO A GENERAL ISSUE WITH THE ANALYZER AND REAGENT CAN BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164690 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR