BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 3316975 · Received August 29, 2013

    Report

    Report Number
    1823260-2013-05296
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    August 7, 2013
    Report Date
    October 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE WENT BACK ON SITE AND REPLACED THE EIO PRINTED CIRCUIT BOARD. THE ISSUE WAS RESOLVED AFTER REPLACING THE PRINTED CIRCUIT BOARD.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE FERRITIN, THYROTROPIN (TSH), VITAMIN B12, PARATHYROID HORMONE (PTH), FREE PROSTATE-SPECIFIC ANTIGEN (FPSA), CARBOHYDRATE ANTIGEN 19-9 (CA 19-9), PRO-BNP, AND TROPONIN T HS (WHICH IS NOT SOLD IN THE UNITED STATES) ON THEIR COBAS E602 ANALYZER. THE CUSTOMER STATED THEY RECEIVED ABNORMAL SIPPER MOVEMENT ALARMS ON THE LATE SHIFT ON (B)(6) 2013. IN THE MORNING OF (B)(6) 2013, THE CUSTOMER PERFORMED DAILY QUALITY CONTROL AND SEVERAL ASSAYS WERE NOT OK. THE CUSTOMER RINSED THE PV AND PERFORMED QUALITY CONTROL AGAIN WITH GOOD RESULTS. THE CUSTOMER REPEATED A FEW PATIENT SAMPLES WITH A BIG DIFFERENCE BETWEEN THE INITIAL AND REPEAT RESULTS. THE CUSTOMER THEN DECIDED TO REPEAT ALL SAMPLES TESTED BEFORE THE ALARM. THE CUSTOMER REPEATED APPROXIMATELY 140 SAMPLES. THE CUSTOMER PROVIDED DATA FOR 39 PATIENTS, OF WHICH 32 HAD DISCREPANT RESULTS. ALL THE DISCREPANT RESULTS WERE REPORTED OUTSIDE THE LABORATORY. AFTER REPEATING THE SAMPLES, THE INITIAL RESULTS WERE DELETED FROM THE LABORATORY INFORMATION SYSTEM AND REPLACED WITH THE REPEAT RESULTS. THE REPEAT TESTING WAS PERFORMED ON (B)(6) 2013. INFORMATION ON WHETHER THE PATIENTS WERE ADVERSELY AFFECTED WAS REQUESTED BUT NOT PROVIDED. THE CA19-9 REAGENT LOT NUMBER WAS 170905. THE FPSA REAGENT LOT NUMBER WAS 171472. THE FERRITIN REAGENT LOT NUMBER WAS 172013. THE PTH REAGENT LOT NUMBER WAS 171868. THE TSH REAGENT LOT NUMBER WAS 173444. THE VITAMIN B12 REAGENT LOT NUMBER WAS 172593. THE FIELD SERVICE REPRESENTATIVE WENT ON SITE AND PERFORMED MAINTENANCE. HE CHECKED AND CLEANED THE SIPPER UNITS WHICH WERE OK WITH NO MALFUNCTIONS. HE RINSED AND CLEANED THE CHANNEL 1 TUBING. HE RAN PERFORMANCE TESTING WHICH WAS OK. THE CUSTOMER STATED THAT AFTER THIS MAINTENANCE, THE SAMPLES WERE REPEATED AS DESCRIBED ABOVE. ON (B)(6) 2013, THE FIELD SERVICE REPRESENTATIVE REPLACED THE MEASURING CELLS WHICH HAD BEEN ON THE ANALYZER FOR 28 MONTHS. IT IS RECOMMENDED TO REPLACE THE MEASURING CELLS AFTER 50,000 TESTS OR 12 MONTHS. AFTER THIS, THE ISSUE HAS NOT RE-OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426443 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1