BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 6345627 · Received February 21, 2017

    Report

    Report Number
    1823260-2017-00388
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Date of Event
    February 3, 2017
    Report Date
    March 21, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. AN ISSUE WITH THE PREANALYTIC HANDLING OF THE SAMPLE WAS THE MOST LIKELY ROOT CAUSE AS THE CUSTOMER WAS USING A TOO SHORT CENTRIFUGATION TIME. OTHER POSSIBLE CAUSES INCLUDE FOAM ON THE SYSTEM REAGENT OR INSUFFICIENT MAINTENANCE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE INTRAOPERATIVE ELECSYS PTH STAT IMMUNOASSAY RESULT FOR ONE PATIENT SAMPLE THAT WAS QUESTIONED BY THE PHYSICIAN. THE RESULT FOR THE "0 MIN, BASELINE" SAMPLE WAS 363.3 PG/ML WITH A DATA FLAG. THE ORIGINAL RESULT FOR THE "10 MIN POST" SAMPLE WAS 26.55 (27) PG/ML AND WAS REPORTED OUTSIDE THE LABORATORY. WHEN THE RESULT WAS QUESTIONED AND THE SAMPLE WAS REPEATED, THE RESULT WAS 318.5 (319) PG/ML WITH A DATA FLAG. THE ORIGINAL RESULT FOR THE "20 MIN POST" SAMPLE WAS 228.1 PG/ML WITH A DATA FLAG AND THE REPEAT RESULT WAS 213.6 (214) PG/ML WITH A DATA FLAG. THE CUSTOMER STATED THE PATIENT WAS "CLOSED UP" AFTER THEY RECEIVED THE 26.55 (27) PG/ML. ONCE THE RESULT FOR THE 20 MIN POST SAMPLE WAS CONFIRMED, THE CUSTOMER TRIED TO REACH THE STAFF BUT THE PATIENT WAS ALREADY AWAKE AND BACK IN RECOVERY. AS THIS WAS AN OUTPATIENT PROCEDURE, THE PATIENT WAS SENT HOME AND HAD TO RETURN TO REPEAT THE SURGERY ON THE NEXT DAY. THE PATIENT'S CURRENT CONDITION WAS PROVIDED AS "DISCHARGED, STABLE". THERE WAS NO ADVERSE EVENT FOR THE PATIENT. THE REAGENT LOT NUMBER WAS 143261. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE FOUND POSSIBLY A BUBBLE WAS ASPIRATED BY THE PROBE DURING THE SWITCH OVER OF PROCELL AND CLEANCELL SOLUTION BOTTLE SETS. HE CHECKED THE FLUIDICS FOR POSSIBLE LEAKS, CHECKED THE PROBE CLOT DETECT, THE PROBE LIQUID LEVEL DETECTION (LLD) VOLTAGE, AND CHECKED THE MIXER SPEED. ALL WERE WITHIN SPECIFICATION. HE PERFORMED A QC PRECISION TEST AND THE RESULTS WERE STABLE. HE FOUND THE ANALYZER WAS WITHIN SPECIFICATION. THE CALIBRATION AND QC WERE ACCEPTABLE ON THE DAY OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129441 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1