BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 6424041 · Received March 22, 2017

    Report

    Report Number
    1823260-2017-00612
    Event Type
    Malfunction
    Date Received
    March 22, 2017
    Date of Event
    March 1, 2017
    Report Date
    March 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
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE LOW RESULTS FOR CALCIUM, PHOSPHORUS, UREA, AND HDL-CHOLESTEROL FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES OVER SEVERAL DAYS. OF THE DATA PROVIDED FOR ONE PATIENT, ONLY THE FOLLOWING RESULTS WERE DISCREPANT. CALCIUM: INITIAL = 2.14 MMOL/L. REPEATS = 1.79, 2.28, 2.27, AND 2.27 MMOL/L. UREA: INITIAL = 37 MG/DL. REPEATS = 47, 45, 24 MG/DL. HDL: INITIAL = 6.8 MG/DL. REPEATS = 64.0, AND 63.8 MG/DL. INFORMATION CONCERNING IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED, BUT IT WAS UNKNOWN. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CALCIUM REAGENT LOT NUMBER WAS 200966. THE UREA REAGENT LOT NUMBER WAS 212533. THE HDL REAGENT LOT NUMBER WAS 200769. THE EXPIRATION DATES WERE REQUESTED BUT WERE NOT PROVIDED. THE CUSTOMER CLEANED THE SAMPLE PROBE AND PERFORMED REPEATABILITY TESTING. THE FIELD SERVICE REPRESENTATIVE FOUND SOME CUVETTE SEGMENTS WERE BROKEN, SOME RINSE UNIT NEEDLES WERE CLOGGED, AND THERE WERE SOME DROPLETS FROM THE BLANK CELL NEEDLE. AFTER REPLACING CUVETTES AND BLANK CELL TUBING, AND CLEANING THE NEEDLES, IT WAS VERIFIED THAT THE ANALYZER WAS WORKING TO SPECIFICATION. CALIBRATION AND QC WERE ACCEPTABLE. THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO MOST LIKELY BE CONTAMINATION DUE TO LACK OF MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206673 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1