BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 602 MODULE

    MDR report key: 6440540 · Received March 28, 2017

    Report

    Report Number
    1823260-2017-00661
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    March 9, 2017
    Report Date
    March 28, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED ALARMS ON CALIBRATIONS FOR A STANDBY PACK OF ELECSYS HCG + BETA TEST SYSTEM REAGENT AND FOUND QUESTIONABLE RESULTS HAD BEEN RECEIVED FOR AT LEAST THREE PATIENT SAMPLES FROM THE ACTIVE PACK OF THE REAGENT. THE INITIAL RESULTS FROM SECONDARY SAMPLE TUBES WERE POSITIVE AND WERE REPORTED OUTSIDE THE LABORATORY. THE PHYSICIAN QUESTIONED THE RESULTS AND THE SAMPLES WERE REPEATED THE NEXT DAY IN SAMPLE CUPS WITH NEGATIVE RESULTS. NO OTHER TESTS WERE AFFECTED. PATIENT 1: INITIAL RESULT WAS 13.68 U/L AND THE REPEAT RESULT WAS <0.1 U/L. PATIENT 2: INITIAL RESULT WAS 20.47 U/L AND THE REPEAT RESULT WAS 5.89 U/L. PATIENT 3: INITIAL RESULT WAS 33.08 U/L AND THE REPEAT RESULT WAS 0.923 U/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 210151. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE CHECKED THE ANALYZER AND FOUND THE SAMPLE PROBE WAS MISADJUSTED AND THE LIQUID LEVEL DETECTION OF THE SAMPLE PROBE WAS INCORRECT AND WAS ADJUSTED FURTHER INVESTIGATION CONFIRMED THE ISSUE FOUND BY THE FIELD SERVICE REPRESENTATIVE WAS THE ROOT CAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223178 COBAS 8000 E 602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1