BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 7881257 · Received September 17, 2018

    Report

    Report Number
    1823260-2018-03163
    Event Type
    Malfunction
    Date Received
    September 17, 2018
    Date of Event
    August 28, 2018
    Report Date
    September 17, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630937103
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS HCG + BETA TEST SYSTEM (HCGB) ON A COBAS E 411 IMMUNOASSAY ANALYZER. TEST RESULTS WERE NOT ACCURATE WHEN DILUTING THE SAMPLE. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO UNITS OF MEASURE WERE PROVIDED FOR THE HCGB ASSAY. THE SAMPLE WAS DILUTED 1:20, INITIALLY RESULTING AS 549. 3. THE SAMPLE WAS REPEATED, RESULTING AS > 10000. THE SAMPLE WAS THEN DILUTED 1:20 AND REPEATED TWO MORE TIMES, RESULTING AS 50650 AND 22166. THE PIPETTOR ASSEMBLY OF THE ANALYZER WAS FOUND TO BE NOT VERTICAL. THE PIPETTOR ASSEMBLY WAS ADJUSTED. AFTER THE ADJUSTMENT, THE SAMPLE WAS DILUTED AND THEN REPEATED 7 ADDITIONAL TIMES, RESULTING WITH THE FOLLOWING VALUES: 92803 (1:20 DILUTION); 86397 (1:20 DILUTION); 50650 (1:20 DILUTION); 93955 (1:20 DILUTION); 90503 (1:10 DILUTION); 86953 (1:10 DILUTION); 83033 (1:10 DILUTION). THE ANALYZER WAS THEN CLEANED USING A 3% PERHYDROL SOLUTION. AFTER CLEANING, THE SAMPLE WAS THEN DILUTED 1:20 AND THREE ADDITIONAL TIMES, RESULTING WITH VALUES OF 94636, 96044, AND 95604. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE QUALITY CONTROL RESULTS WERE NORMAL. THE INSTRUMENT NOW WORKS NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722399 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 DISK NA 04015630937103

    Patients

    Seq Age Sex Outcome Treatment
    1