BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 2221901 · Received August 24, 2011

    Report

    Report Number
    1823260-2011-04543
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 8, 2011
    Report Date
    September 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHP
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. POSSIBLE CAUSES IDENTIFIED WERE SAMPLE PREANALYTIC RELATED INCLUDING INADEQUATE CENTRIFUGATION PARAMETERS. NO DEVICE ISSUES WERE SUSPECTED AS ALL CALIBRATION, QUALITY CONTROL AND PERFORMANCE TESTING DATA WAS WITHIN SPECIFICATIONS. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS NOT ADVERSELY AFFECTED.

    Description of Event or Problem · 1

    THE FIELD APPLICATION SPECIALIST REPORTED THE USER RECEIVED A QUESTIONABLE ESTRADIOL RESULT FOR ONE PATIENT SAMPLE. THEN INITIAL RESULT WAS 3402 PG/ML WITH A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED ON (B)(6) 2011. THE REPEAT RESULT WAS 77.70 PG/ML. IT WAS NOTED TWO LITHIUM HEPARIN SAMPLES HAD BEEN DRAWN FROM THE PATIENT. THE USER WAS NOT SURE WHICH ON TUBE THE INITIAL AND REPEAT TESTING WAS PERFORMED. THE PATIENT WAS NOT ADVERSELY AFFECTED AS THE DOCTOR DID NOT ACT UPON THE INITIAL RESULT. THE ESTRADIOL REAGENT LOT NUMBER WAS 16235101. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE OR ISSUE WITH THE CONDITION OR OPERATION OF THE ANALYZER. HE CHECKED THE SIPPER AND PROBE FOR ANY SIGNS OF WEAR OR DAMAGE AND NO ISSUES WERE NOTED. HE CHECKED THE CONDITION OF THE SYRINGE MECHANISM FOR WEAR OR DAMAGE AND NO ISSUES WERE NOTED. HE CHECKED THE CONDITION OF PINCH TUBING AND NO EXCESSIVE WEAR WAS NOTED. HE CHECKED ALL MECHANICAL ADJUSTMENTS AND ALL ADJUSTMENTS WERE CORRECT AND AS DESIGNED. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE TESTING WITH ALL RESULTS WITHIN THE EXPECTED LIMITS. THE USER RAN CALIBRATION AND QUALITY CONTROL WITH RESULTS WITHIN LIMITS. THE FIELD APPLICATION SPECIALIST REVIEWED THE PATIENT DATA, GATHERED CALIBRATION AND QUALITY CONTROL DATA AND RETESTED THE PATIENT SAMPLES. SHE DETERMINED IT APPEARED THAT THE SAMPLE MAY HAVE BEEN MANUALLY PROGRAMMED AND THAT POSSIBLY THE WRONG SAMPLE WAS PLACED IN THE ASSIGNED POSITION. THE FIELD APPLICATION SPECIALIST REPEATED THE TWO LITHIUM HEPARIN PLASMA SAMPLES ON (B)(6) 2011 WITH RESULTS OF 80.39 AND 78.12 PG/ML. SHE ALSO TESTED AN EDTA PLASMA SAMPLE FROM THE PATIENT WITH A RESULT OF 90.01 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER CHP ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 047 YR