BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 502 MODULE

    MDR report key: 6864151 · Received September 14, 2017

    Report

    Report Number
    1823260-2017-01974
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    August 22, 2017
    Report Date
    October 31, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION CONCLUDED THAT A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE CALIBRATION PERFORMED BEFORE THE DAY OF EVENT AND THE CALIBRATION PERFORMED FOLLOWING THE DAY EVENT WERE BOTH ACCEPTABLE AND CONSISTENT WITH ONE ANOTHER. THESE CALIBRATIONS WERE PERFORMED USING TWO SEPARATE REAGENT PACKS WITH THE SAME LOT NUMBER (219418). THE PREVIOUS LOT OF REAGENT (220196) ALSO HAD CALIBRATION VALUES CONSISTENT TO REAGENT LOT 219418. FURTHERMORE THE QC RESULTS FOR ALL 3 LEVELS ON THE DAY OF THE EVENT WEAR NEAR THEIR TARGET VALUES. THEREFORE A PROBABLE CAUSE IS A PRE-ANALYTICAL ISSUE THAT COULD HAVE CONTAMINATED THE SAMPLE PROBE. THE SPORADIC CONTAMINATION COULD HAVE BEEN CAUSED BY FIBRIN, PROTEINS, OR GEL THAT RESOLVED ITSELF DURING THE SUBSEQUENT PRECISION TESTING.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)# (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER NOTED THAT THERE WERE NO ACTIONS OR ANY SERVICE PERFORMED BETWEEN THE TIME WHEN THEY SWITCHED OUT THE OLD REAGENT PACK WITH A NEW REAGENT PACK. FOLLOWING THE REAGENT PACK CHANGE, CALIBRATION AND CONTROL RESULTS HAVE BEEN ACCEPTABLE ALONG WITH NO FURTHER COMPLAINTS. A FIELD ENGINEERING SPECIALIST WAS DISPATCHED TO CHECK THE INSTRUMENT. HE WAS UNABLE TO FIND ANY PROBLEMS. HE PERFORMED MECHANICAL CHECKS AND EVERYTHING WAS WITHIN SPECIFICATIONS. HE PERFORMED PRECISION TESTING OF A CONTROL MATERIAL WHICH WAS ALSO WITHIN SPECIFICATIONS. IT WAS ALSO NOTED THAT THE 24 OTHER ASSAYS ON THE INSTRUMENT ARE PERFORMING WITHIN TOLERANCE AND THERE HAVE BEEN NO OTHER ISSUES REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A PHYSICIAN QUESTIONED ONE PATIENT¿S VANC3 VANCOMYCIN TROUGH RESULT. THE INITIAL RESULT WAS 61.1 UG/ML. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER WITH A RESULT OF 16 UG/ML. THE SAMPLE WAS THEN REPEATED ON A SECOND ANALYZER WITH A RESULT OF 15.4 UG/ML. THE REPEAT RESULT FROM THE SECOND ANALYZER WAS DEEMED TO BE CORRECT. A CORRECTED REPORT HAD TO BE ISSUED. THE PATIENT WAS NOT TREATED DUE TO THE INITIAL RESULT. THERE WAS NO ADVERSE EVENT. THE COBAS 8000 C 502 MODULE SERIAL NUMBER IS (B)(4). THE CUSTOMER PERFORMED A PRECISION RUN FOR VANCOMYCIN AND OBTAINED A COEFFICIENT OF VARIATION (CV) OF 15%. THE CUSTOMER INSTALLED A NEW CASSETTE, REPEATED THE PRECISION RUN AND OBTAINED A CV OF 4.3%. THE CUSTOMER STATES THAT THEY HAVE HAD NO FURTHER PROBLEMS WITH VANCOMYCIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644897 COBAS 8000 C 502 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C502 21941801

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR