BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 602 MODULE

    MDR report key: 6630795 · Received June 9, 2017

    Report

    Report Number
    1823260-2017-01197
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    March 21, 2017
    Report Date
    July 6, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE CAUSES INCLUDE AN ISSUE WITH THE PREANALYTIC HANDING OF THE SAMPLES. IT WAS RECOMMENDED TO RETEST THE PATIENTS WITH A NEW SAMPLE.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE HIGH ELECSYS AFP ASSAY RESULTS FOR MULTIPLE PATIENT SAMPLES AND SUSPECTED CARRYOVER FROM ONE SAMPLE TESTED PRIOR TO THESE SAMPLES THAT HAD A RESULT OF >60500 NG/ML. FOR ONE PATIENT, THE INITIAL RESULT WAS "80". THE DOCTOR DOUBTED THE RESULT AS IT WAS NOT CONSISTENT WITH THE PREVIOUS RESULTS AND CLINICAL SYMPTOMS FOR THE PATIENT. AS THE SAMPLE HAD BEEN DISCARDED, A NEW SAMPLE WAS DRAWN FROM THE PATIENT ON (B)(6) 2017. THE RESULT FROM THE NEW SAMPLE WAS "1". SPECIFIC DATA FOR THIS SAMPLE WAS NOT PROVIDED. DATA WAS PROVIDED FOR SIX PATIENT SAMPLES QUESTIONED BY THE CUSTOMER BASED ON THE PREVIOUS RESULT FOR THE PATIENT. THESE SAMPLES WERE DISCARDED AND COULD NOT BE REPEATED. DATA WAS ALSO PROVIDED FOR ONE PATIENT SAMPLE WHERE THE ORIGINAL SAMPLE AND AN ADDITIONAL SAMPLE FROM THE DAY OF THE EVENT WERE REPEATED. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 120174. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION REVIEWED ALL AFP RESULTS PROVIDED FROM THE DAY OF THE EVENT AND DETERMINED CARRYOVER FROM THE HIGH SAMPLE WAS NOT LIKELY AS THE SAMPLES IMMEDIATELY FOLLOWING THIS SAMPLE DID NOT HAVE ELEVATED RESULTS OR DATA FLAGS INDICATING CARRYOVER. REVIEW OF THE PROVIDED CALIBRATION AND QC DATA FOUND ALL WERE ACCEPTABLE AND IN RANGE. BASED ON THE PROVIDED DATA, A GENERAL DEVICE ISSUE WAS EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412960 COBAS 8000 E 602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1