BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 SYSTEM

    MDR report key: 3869460 · Received June 12, 2014

    Report

    Report Number
    1823260-2014-04299
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 22, 2014
    Report Date
    July 15, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLB
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. BASED ON THE PROVIDED CALIBRATION DATA, GENERAL REAGENT ISSUES WERE NOT SUSPECTED.

    Additional Manufacturer Narrative · 1

    INFORMATION CONCERNING THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT WAS REQUESTED, BUT WAS NOT PROVIDED. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE CK-MB - THE MB ISOENZYME OF CREATINE KINASE STAT AND TROPONIN I STAT RESULTS FOR ONE PATIENT. THE INITIAL CKMB RESULT WAS 300 NG/ML WITH A DATA FLAG. THE INITIAL TROPONIN I RESULT WAS 25.00 NG/ML WITH A DATA FLAG. THE REPEAT CKMB RESULT WHEN DILUTED 1:10 WAS 41.28 NG/ML WITH A DATA FLAG. THE REPEAT TROPONIN I RESULT WHEN DILUTED 1:10 WAS 23.21 NG/ML WITH A DATA FLAG. THESE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE SECOND REPEAT CKMB RESULT WHEN DILUTED 1:10 WAS 404.7 NG/ML WITH A DATA FLAG. THE SECOND REPEAT TROPONIN I RESULT WHEN DILUTED 1:10 WAS 197.9 NG/ML WITH A DATA FLAG. THESE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CKMB REAGENT LOT NUMBER WAS 174105 AND THE TROPONIN I REAGENT LOT NUMBER WAS 174423. THE EXPIRATION DATES WERE REQUESTED, BUT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348284 COBAS E411 SYSTEM IMMUNOCHEMISTRY ANALYZER JLB ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 069 YR PLAVIX| CLEXANE| ALDACTONE| RIVOTRIL