BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 602 MODULE

    MDR report key: 6506978 · Received April 20, 2017

    Report

    Report Number
    1823260-2017-00829
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Date of Event
    April 4, 2017
    Report Date
    May 22, 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).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED AND THE SAMPLE APPEARED VERY VISCOUS AND GEL-LIKE. THIS COULD INDICATE AN ISSUE WITH PRE-ANALYTICS. NO PREANALYTIC INFORMATION WAS PROVIDED FOR THE INVESTIGATION. IN THE ANALYZER ALARM TRACE PROVIDED, AN ERROR MESSAGE INDICATING AN ISSUE WITH THE MEASURING CELL WAS FOUND. IF THE MEASURING CELL WAS BLOCKED BY SAMPLES OF BAD QUALITY, THIS COULD BE A POSSIBLE ROOT CAUSE. AN ADDITIONAL POSSIBLE ROOT CAUSE FOR THIS TYPE OF EVENT WAS INSUFFICIENT MAINTENANCE OF THE ANALYZER.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE HIGH ELECSYS VITAMIN D ASSAY RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 13.3 NMOL/L. THE REPEAT RESULTS WERE 73.8 NMOL/L AND 7.76 NMOL/L. INFORMATION CONCERNING IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED, BUT IT WAS UNKNOWN. THE RESULTS OF 13.3 NMOL/L AND 7.76 NMOL/L WERE BELIEVED TO BE CORRECT FOR THE PATIENT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 211769. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE CHECKED THE ANALYZER AND FOUND AN ISSUE WITH THE QUANTITY OF THE LIQUID LEVEL DETECTION (LLD) WASH WATER AND AN ISSUE WITH THE SAMPLE PIPETTE POSITION. THESE ISSUES WERE CORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290825 COBAS 8000 E 602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1