BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 5303440 · Received December 16, 2015

    Report

    Report Number
    1823260-2015-06055
    Event Type
    Malfunction
    Date Received
    December 16, 2015
    Date of Event
    November 19, 2015
    Report Date
    December 16, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS FOR PATIENT SAMPLES AND CONTROL MATERIAL. OF THE DATA PROVIDED FOR 45 PATIENT SAMPLES. ONLY THE RESULTS FOR 29 WERE DISCREPANT. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE UNITS OF MEASURE WERE NOT PROVIDED. THE INITIAL RUN RESULTS WERE REPORTED TO A DOCTOR. THERE WAS NO ADVERSE EVENT. THE REAGENT EXPIRATION DATES WERE REQUESTED, BUT WERE NOT PROVIDED. THE LOT NUMBERS WERE: THYROTROPIN (TSH) 187024. FREE THYROXINE (FT4) 184927. ALPHA1-FETOPROTEIN (AFP) 184305. FREE TRIIODOTHYRONINE (FT3) 183221. FERRITIN 187143. TOTAL PSA TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TOTAL PSA) 186769. CARCINOEMBRYONIC ANTIGEN (CEA) 185168. CARBOHYDRATE ANTIGEN 19-9 (CA19-9) 181925. AFTER CHANGING THE PINCH BULB TUBE AND CLEANING THE PROBE, NO FURTHER ISSUE WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831228 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1