BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 6508181 · Received April 20, 2017

    Report

    Report Number
    1823260-2017-00834
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    April 4, 2017
    Report Date
    May 23, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT WAS NOT INCORRECTLY TREATED BASED ON THE ERRONEOUS RESULT. THE FIELD SERVICE REPRESENTATIVE FOUND FOAM IN THE REAGENT PACK SO HE ADJUSTED THE BEAD MIXER PADDLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CLARIFICATION WAS PROVIDED THAT THE FIELD SERVICE REPRESENTATIVE REPLACED THE BEAD MIXER PADDLE REPLACEMENT AND THEN PERFORMED ADJUSTMENTS. THE CUSTOMER STATED CALIBRATION AND QC RESULTS WERE IN THE ACCEPTABLE RANGE AFTER THE SERVICE VISIT. THE CUSTOMER HAS NOT REPORTED ANY ADDITIONAL EVENTS. THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE, BUT COULD NOT EXCLUDE THE FOAM ON THE REAGENT SURFACE HAD AN IMPACT ON THE REPORTED SAMPLE RESULT.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ELECSYS PROBNP II IMMUNOASSAY AND ELECSYS PTH IMMUNOASSAY. OF THE DATA PROVIDED, ONLY THE RESULTS FOR PTH WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE INITIAL RESULT FROM THE PRIMARY SAMPLE TUBE WAS 17.60 NG/L AND WAS REPORTED. THE REPEAT RESULTS FROM AN ALIQUOT IN A CUP WERE 1288 NG/L AND 1297 NG/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 143251. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE CUSTOMER STATED ALL CALIBRATION AND QC RESULTS WERE WITHIN THE ACCEPTABLE RANGE. THE FIELD SERVICE REPRESENTATIVE CHECKED THE INSTRUMENT AND PERFORMED PREVENTIVE MAINTENANCE. HE REPLACED THE PIPETTE NOZZLE AND THE BEAD MIXER PADDLE. HE INSTALLED A UPS SYSTEM TO AVOID ELECTRIC INTERFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289527 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR