BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 2935772 · Received January 30, 2013

    Report

    Report Number
    1823260-2013-00544
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR TROPONIN T STAT (SHORT TURN AROUND TIME). THE SAMPLE INITIALLY RESULTED AS 0.049 NG/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED AND RESULTED AS 0.115 NG/ML ACCOMPANIED BY A DATA FLAG. THE CUSTOMER THEN POURED OFF THE SAMPLE AND RAN IT IN A CUP FOR A SECOND REPEAT, RESULTING AS 0.053 NG/ML ACCOMPANIED BY A DATA FLAG. THE CUSTOMER ALSO PULLED AN EDTA TUBE FROM THE SAME COLLECTION AND RAN IT FOR A THIRD REPEAT, RESULTING AS 0.056 NG/ML ACCOMPANIED BY A DATA FLAG. THE ORIGINAL RESULT WAS BELIEVED TO BE CORRECT AND A RESULT OF 0.05 NG/ML WAS RELEASED OUTSIDE OF THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE TROPONIN T STAT REAGENT LOT NUMBER WAS 17016701 WITH AN EXPIRATION DATE OF 11/30/2013. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT A HAIRLINE CRACK IN THE PLASTIC INSULATION TIP OF THE S/R PROBE AND A BENT SAMPLE SIPPER NOZZLE PROBE WERE CONTRIBUTING FACTORS. THERE WAS ALSO EXTREMELY LOW HUMITIDY OF 15% TO 19% IN THE LABORATOY AT THE LOCATION OF THE INSTRUMENT. HE REPLACED THE S/R PROBE AND TUBING. HE REPLACED THE SAMPLE SIPPER NOZZLE. HE ALSO REPLACED THE MEASURING CELL FOR PREVENTIVE MAINTENANCE PURPOSES. HE PERFORMED ALL PROBE ADJUSTMENTS, CHECKED LLD VOLTAGES AND PRESSURE SENSOR VOLTAGES. THE MIXER SPEED CHECKED GOOD. THE INCUBATOR, PC/CC, AND MEASURING CELL TEMPERATURES WERE ALL GOOD. THE PINCH TUBING WAS REPLACED. PERFORMANCE TESTS WERE PERFORMED WITH ALL RESULTS MEETING SPECIFICATIONS. THE OPERATOR PERFORMED CALIBRATIONS AND QUALITY CONTROL WITH ALL RESULTS FOR TROPONIN T STAT AND PROBNP MEETING SPECIFICATIONS. THE CALIBRATIONS HAD TO BE PERFORMED TWICE AND QUALITY CONTROLS REPEATED DUE TO CONTROL ISSUES AFTER THE FIRST GOOD CALIBRATION. CRITICAL HUMIDITY AND STATIC ISSUES WERE SUSPECTED WITHIN THE LAB. THE LABORATORY HUMIDITY WAS 15% ACCORDING TO THE FIELD SERVICE REPRESENTATIVE'S GUAGE AND 19% ON THE LABORATORY HUMIDITY GUAGE. STATIC ISSUES WERE NOTICED WITH CUPS. THE CUSTOMER WAS INFORMED OF THE INSTRUMENT HUMIDITY SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41301 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER MMI ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 088 YR PERCOCET| LASIX| CARVEDILOL| ASPIRIN| LISINOPRIL| TAMSULOSIN| SYNTHYROID