BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 8019810 · Received October 30, 2018

    Report

    Report Number
    1823260-2018-03905
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Date of Event
    October 8, 2018
    Report Date
    January 8, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946198
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) CHECKED THE ADJUSTMENT OF THE SIPPER, PRE-WASH AND THE SAMPLE PROBES AND ALL WERE CORRECTLY ADJUSTED. LIQUID LEVEL DETECTION WAS CHECKED AND THE VOLTAGE WAS CORRECT. THERE WAS NO TURBIDITY IN THE PROCELL SYRINGES. THE TUBING FROM THE TOP OF THE SYRINGE DOWN TO THE VALVE HAD A LAYER INSIDE. THE TUBES WERE DECONTAMINATED AND ARE NOW CLEAN.

    Additional Manufacturer Narrative · 0

    NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. EXTENSIVE ANALYSIS OF INSTRUMENT DATA AND THE SAMPLE FOAM DETECTION IMAGES FROM THE INSTRUMENT WERE REVIEWED. THE INVESTIGATION DETERMINED THE EVENT OCCURRED DUE TO REDUCED TRANSFER OF SAMPLE VOLUME DUE TO A POOR ADJUSTMENT OF THE COMPONENTS OF THE SAMPLING AREA. THE COMPONENTS OF THE SAMPLING AREA WERE ADJUSTED. THE INVESTIGATION REVIEWED IMAGES FROM THE INSTRUMENT AND THE COMPONENTS APPEAR TO BE ADJUSTED PROPERLY, PROVIDING GOOD SUPPORT TO THE SAMPLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED LOW RESULTS FOR 26 SAMPLES TESTED FOR MULTIPLE ASSAYS ON 4 COBAS E801 MODULES. BASED ON THE DATA PROVIDED, THE RESULTS FOR 25 PATIENTS WERE DISCREPANT WHEN TESTED FOR ELECSYS FERRITIN (FERRITIN), ELECSYS FOLATE (FOLATE), ELECSYS VITAMIN B12 II (VITAMIN B12 II), ELECSYS TSH (TSH), ELECSYS TOTAL PSA (TOTAL PSA), ELECSYS CEA, (CEA) AND ELECSYS FT3 III (FT3 III) BETWEEN ALL 4 E801 MODULES. THIS MEDWATCH WILL COVER E801 MODULE 1753-08. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON E801 MODULE 1626-16, MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON E801 MODULE 1627-03 AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON E801 MODULE 1627-04. REFER TO ATTACHED DATA FOR THE PATIENT RESULTS. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE FERRITIN REAGENT LOT NUMBER WAS 349472. THE EXPIRATION DATE WAS NOT PROVIDED. THE FOLATE REAGENT LOT NUMBER WAS 319846. THE EXPIRATION DATE WAS NOT PROVIDED. THE VITAMIN B12 II REAGENT LOT NUMBER WAS 330946. THE EXPIRATION DATE WAS NOT PROVIDED. THE TSH REAGENT LOT NUMBER WAS 331814. THE EXPIRATION DATE WAS NOT PROVIDED. THE CEA REAGENT LOT NUMBER WAS 319112. THE EXPIRATION DATE WAS NOT PROVIDED. THE TOTAL PSA REAGENT LOT NUMBER WAS 340180. THE EXPIRATION DATE WAS NOT PROVIDED. THE FT3 III REAGENT LOT NUMBER WAS 314824. THE EXPIRATION DATE WAS NOT PROVIDED. THE CUSTOMER HAS REPLACED THE SAMPLE PROBES, HOWEVER, THE PROBLEM HAS NOT BEEN SOLVED. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860752 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 NA 04015630946198

    Patients

    Seq Age Sex Outcome Treatment
    1