BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 2625099 · Received June 21, 2012

    Report

    Report Number
    1823260-2012-03289
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Date of Event
    June 1, 2012
    Report Date
    July 18, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDZ
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. CALIBRATION AND QUALITY CONTROL DATA WERE WITHIN SPECIFICATION AND THERE WERE NO REAGENT ISSUES EVIDENT. IT WAS NOTED THE CUSTOMER WAS NOT FOLLOWING THE TUBE MANUFACTURER'S CENTRIFUGATION SPECIFICATIONS. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE TESTOSTERONE (TESTO) G2 RESULTS ON THEIR COBAS E411 ANALYZER. THE CUSTOMER PROVIDED DATA FOR FIVE PATIENTS, OF WHICH TWO PATIENTS HAD DISCREPANT RESULTS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER STATED "THE RERUN RESULT ERE REPORTED AND BECAUSE OF AUTO VERIFICATION ENABLED ON THEIR LIS, SO THEY HAD TO SEND AN EDITED REPORT TO THE DOCTOR". THE FIRST PATIENT HAD AN INITIAL TESTO RESULT OF <0.42 NMOL/L ACCOMPANIED BY A DATA FLAG FROM A PIPETTED ALIQUOT. THE REPEAT RESULT WAS 16.35 NMOL/L. THE SECOND PATIENT, A (B)(6) MALE, HAD AN INITIAL TESTO RESULT OF <0.42 NMOL/L ACCOMPANIED BY A DATA FLAG FROM A PIPETTED ALIQUOT. THE REPEAT RESULT WAS 13.99 NMOL/L. THERE WERE NO ADVERSE EVENTS. THE TESTO REAGENT LOT NUMBER WAS 16677701 AND THE EXPIRATION DATE WAS NOT PROVIDED. BASED ON THE ASSAY PERFORMANCE CHECK, THE FIELD SERVICE REPRESENTATIVE (FSR) EXCHANGED THE MEASURING CELL, BUT THIS DID NOT SOLVE THE ISSUE. LATER, THE FSR FOUND AN ISSUE WITH THE GROUNDING OF THE SAMPLE DISK WHICH HAS A DIRECT INFLUENCE ON THE PERFORMANCE OF THE LIQUID LEVEL DETECTOR (LLD). THE FSR NOTICED THE TUBE HOLDER WAS VERY LOOSE, AND IT WAS RECOMMENDED THE SAMPLE DISK BE REPLACED. THESE ISSUES WOULD EXPLAIN THE SPORADIC LLD ISSUES AND THE LOW RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR