BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 7133227 · Received December 20, 2017

    Report

    Report Number
    1823260-2017-03066
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    December 12, 2017
    Report Date
    January 23, 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
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS SOLVED AFTER THE SERVICE ACTIONS WERE PERFORMED. THE ROOT CAUSE OF THE ISSUE WAS INCOMPLETE MAINTENANCE OF THE ANALYZER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY WERE HAVING INTERMITTENT ISSUES WITH AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED FOR PHOS2 PHOSPHATE (INORGANIC) VER.2 - PHOS ON A COBAS 8000 C 702 MODULE (C702). THE INITIAL RESULTS WILL BE HIGH AND THEN REPEAT RESULTS WILL BE HALF OF THE INITIAL VALUE. THE CUSTOMER PROVIDED DATA FOR TWO PATIENT SAMPLES THAT HAD ERRONEOUS INITIAL RESULTS. THE REPEAT RESULTS FOR THESE SAMPLES WERE BELIEVED TO BE CORRECT. THE FIRST SAMPLE WAS POURED INTO A FALSE BOTTOM TUBE AND TESTED ON THE ANALYZER, INITIALLY RESULTING AS 10.9 MG/DL. THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED, RESULTING AS 4.5 MG/DL. THE SECOND SAMPLE, FROM A (B)(6) YEAR OLD MALE PATIENT BORN ON (B)(6), WAS LOADED THROUGH A COBAS 8100 PRE-ANALYTICS SYSTEM AND TESTED ON THE ANALYZER. THE INITIAL RESULT WAS 12.8 MG/DL. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED, RESULTING AS 5.6 MG/DL AND THIS VALUE WAS BELIEVED TO BE CORRECT. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE PHOS REAGENT LOT NUMBER WAS 250418. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND THAT TWO RINSE NOZZLES WERE NOT ALWAYS GOING DOWN TO THE BOTTOM MOST POSITIONS. HE REMOVED AND CLEANED THE RINSE NOZZLES AND HOLES ON THE RINSE ARMS. HE REPLACED TWO VACUUM LINES THAT WERE LOOKING QUESTIONABLE. HE REPLACED REAGENT PROBES. THE CUSTOMER RAN QUALITY CONTROLS AND ALL WERE OK. THE CUSTOMER DID NOT EXPERIENCE ANY FURTHER ISSUES AFTER THESE ACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913568 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR