BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 602 MODULE

    MDR report key: 6991332 · Received October 31, 2017

    Report

    Report Number
    1823260-2017-02494
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    October 3, 2017
    Report Date
    November 9, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K100853
    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. IT WAS NOTED THAT A HIGH PERCENTAGE OF SAMPLES AT THE SITE HAD FIBRIN, MICRO- FIBRINS, AND/OR BUBBLES. THEREFORE THIS WAS MOST LIKELY THE CAUSE OF THE EVENT. OTHER TYPICAL CAUSES FOR THIS TYPE OF EVENT INCLUDE ISSUES WITH SAMPLE QUALITY OR INSUFFICIENT MAINTENANCE OF THE ANALYZER. BASED ON THE PROVIDED CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE WAS NOT SUSPECTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE LOW ELECSYS HCG + BETA TEST SYSTEM RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 156.3 MIU/ML AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE RESULT WAS QUESTIONED AND THE SAMPLE WAS REPEATED ON (B)(6) 2017 WITH A RESULT OF 46039 MIU/ML. THE REPORTED RESULT WAS CORRECTED AND THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 210151 WITH AN EXPIRATION DATE OF 31-MAY-2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770354 COBAS 8000 E 602 MODULE IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS E602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR