BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 7323029 · Received March 8, 2018

    Report

    Report Number
    1823260-2018-00713
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    February 16, 2018
    Report Date
    April 2, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE INITIAL RESULTS WERE GENERATED FROM ALIQUOTS PROCESSED BY THE COBAS 8100 PREANALYTIC SYSTEM AND THE REPEAT RESULTS WERE GENERATED FROM THE PRIMARY SAMPLE TUBE. THE CUSTOMER CONFIRMED THERE WERE NO FURTHER ISSUES AFTER THE SERVICE VISIT.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE CLEANED AND DECONTAMINATED VARIOUS PART OF THE ANALYZE AND REPLACED THE SAMPLE PROBE. THE CUSTOMER RAN CALIBRATION AND QC WHICH WAS ACCEPTABLE. THE INVESTIGATION CONFIRMED THE ISSUE WAS RESOLVED BY THE SERVICE ACTIONS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE LOW CA2 CALCIUM GEN.2 RESULTS FOR MULTIPLE PATIENT SAMPLES OVER FOUR DAYS. OF THE DATA PROVIDED FOR THREE SAMPLES, ONLY THE RESULTS FOR TWO WERE DISCREPANT. PATIENT 1 INITIAL RESULT WAS 5.7 MG/DL AND THE REPEAT RESULT WAS 9.1 MG/DL. ON (B)(6) 2018, PATIENT 2 INITIAL RESULT WAS 6.6 MG/DL AND THE REPEAT RESULTS WAS 9.1 MG/DL. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER WAS 221425. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE. HE INSPECTED AND CLEANED MULTIPLE PARTS OF THE ANALYZER. THE CUSTOMER PERFORMED CALIBRATION AND QC WHICH WAS ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169052 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1