BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 7086055 · Received December 6, 2017

    Report

    Report Number
    1823260-2017-02849
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Date of Event
    November 20, 2017
    Report Date
    December 6, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS HCG + BETA TEST SYSTEM RESULTS FOR ONE PATIENT SAMPLE. THE INITIAL TESTING DID NOT PRODUCE A NUMERIC RESULT, BUT HAD A DATA FLAG INDICATING A SHORT SAMPLE. THE SAMPLE WAS REPEATED AND THE RESULT WAS 0.100 IU/ML WITH A DATA FLAG. ON (B)(6) 2017, THE SAMPLE WAS REPEATED AND DID NOT PRODUCE A NUMERIC RESULT, BUT HAD A DATA FLAG INDICATING A SHORT SAMPLE. THE REPEAT RESULT IN A SAMPLE CUP WAS 123.5 IU/ML. NO ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 210151. THE EXPIRATION DATE WAS PROVIDED AS "05/2018". A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. TYPICAL CAUSES FOR THIS TYPE OF EVENT INCLUDE ISSUES WITH SAMPLE QUALITY SUCH AS FOAM/AIR BUBBLES ON THE SAMPLE SURFACE OR INSUFFICIENT MAINTENANCE OF THE ANALYZER. A GENERAL POSSIBILITY COULD BE BUBBLES OR FOAM ON THE REAGENT SURFACE OR ON SYSTEM REAGENT SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868281 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1