BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 2063700 · Received April 20, 2011

    Report

    Report Number
    1823260-2011-02133
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    April 3, 2011
    Report Date
    May 5, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. ASSAY PERFORMANCE CHECKS WERE WITHIN SPECIFICATION. QUALITY CONTROLS WERE WITHIN SPECIFICATION. IT WAS DETERMINED THE CUSTOMER IS USING A SAMPLE CENTRIFUGATION TIME THAT IS TOO SHORT AND A SPEED THAT IS TOO HIGH. THIS COULD BE A POSSIBLE CAUSE OF THE ISSUE. THE PATIENT WAS NOT ADVERSELY AFFECTED.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE TROPONIN T STAT GENERATION 4 (TNT) RESULT FOR ONE PATIENT SAMPLE THAT WAS DISCOVERED WHEN A SECOND SAMPLE FROM THE PATIENT WAS TESTED SIX HOURS LATER WITH A LOWER RESULT. THE INITIAL RESULT WAS 0.231 NG/ML WITH A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. THE SECOND SAMPLE WAS DRAWN SIX HOURS LATER ON (B)(6) 2011 AND GAVE A RESULT OF 0.034 NG/ML. ON (B)(6) 2011, THE FIRST SAMPLE WAS RETESTED IN A SAMPLE CUP AND THE RESULT WAS 0.040 NG/ML. AFTER QUALITY CONTROL WAS TESTED, THE SAMPLE WAS RETESTED IN A SAMPLE CUP WITH A RESULT OF 0.041 NG/ML. THE ORIGINAL SAMPLE TUBE WAS THEN RETESTED WITH A RESULT OF 0.043 NG/ML. THE USER BELIEVED THE RESULT OF 0.04 NG/ML TO BE THE CORRECT RESULT FOR BOTH SAMPLES AND ISSUED A CORRECTED REPORT FOR THE FIRST SAMPLE. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TNT REAGENT LOT NUMBER WAS 15989401. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE. HE INSPECTED THE PATIENT SAMPLE WITH NO ABNORMALITIES FOUND AND CHECKED THE MECHANICAL ALIGNMENTS WITH NO PROBLEMS FOUND. HE CHECKED THE SYSTEM FOR PROPER OPERATION BY RUNNING QUALITY CONTROL AND PERFORMANCE TESTING. ALL QUALITY CONTROL RESULTS WERE WITHIN THE USER'S RANGES AND THE PERFORMANCE TESTING RESULTS WERE WITHIN SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 082 YR MIRALAX| SPIRONOLACTONE| ACETAMINOPHEN| PANTOPRAZOLE| METOLAZONE| MEGESTROL ACE| LACTULOSE| GLIPIZIDE| FUROSEMIDE| EXELON PATCH| VALSARTAN| ZOLPIDEM TARTRATE| RISPERIDONE| DALTEPARIN| METOPROLOL| CLONIDINE| DIGOXIN