BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E 601 MODULE

    MDR report key: 6233456 · Received January 9, 2017

    Report

    Report Number
    1823260-2017-00046
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Date of Event
    December 7, 2016
    Report Date
    February 24, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4). PHONE NUMBER WAS PROVIDED AS "(B)(6)".

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER DETERMINED THAT THERE WERE NO ISSUES WITH THE ELECTROMAGNETIC INTERFERENCE. THE POWER SUPPLY IS DEDICATED TO THE ANALYZER AND NO OTHER ANALYZERS ARE CONNECTED. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. CONTROL RESULTS WERE WITHIN THE SPECIFIED LIMITS. THE ABNORMAL SAMPLE PROBE MOVEMENT AND ABNORMAL SAMPLE ASPIRATION ALARMS MAY INDICATE THAT THERE WERE ISSUES WITH PRE-ANALYTIC HANDLING OF THE SAMPLES. AN ISSUE WITH PRE-ANALYTIC SAMPLE HANDLING COULD NOT BE EXCLUDED AS A ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR TWO PATIENT SAMPLES TESTED FOR THE ELECSYS HCG + BETA TEST SYSTEM (HCGB) ON A COBAS 6000 E 601 MODULE (E601). THE SAMPLE FROM THE FIRST PATIENT INITIALLY RESULTED AS 37.08 MUI/ML ON THE E601 ANALYZER AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT COMPLAINED ABOUT THE RESULT BECAUSE SHE WAS NOT PREGNANT. THE SAMPLE WAS REPEATED ON THE E601 ANALYZER ON (B)(6) 2016, RESULTING AS 0.310 MUI/ML. THE SAMPLE WAS REPEATED A SECOND TIME ON THE E601 ANALYZER ON (B)(6) 2016, RESULTING AS 0.395 MUI/ML. A SECOND SAMPLE WAS COLLECTED FROM THE FIRST PATIENT AND TESTED ON THE E601 ANALYZER ON (B)(6) 2016, RESULTING AS 0.424 MUI/ML. THE SAMPLE FROM THE SECOND PATIENT INITIALLY RESULTED AS 322.8 MUI/ML WHEN TESTED ON THE E601 ANALYZER ON (B)(6) 2016. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON THE CENTAUR ANALYZER SINCE MAINTENANCE WAS BEING PERFORMED ON THE E601 ANALYZER. THE REPEAT RESULT FROM THE CENTAUR ANALYZER WAS < 2.0 MUI/ML. THE CUSTOMER STATED THAT THEY WERE THEN REPEATING CALIBRATIONS FOR ALL ASSAYS ON THE E601 ANALYZER. THE SAMPLE WAS REPEATED A SECOND TIME ON THE CENTAUR ANALYZER ON (B)(6) 2016, RESULTING AS < 2.0 MUI/ML. THE SAMPLE WAS REPEATED A THIRD TIME ON THE E601 ANALYZER ON (B)(6) 2016, RESULTING AS < 0.100 MUI/ML. A SECOND SAMPLE WAS COLLECTED FROM THE SECOND PATIENT AND TESTED ON THE E601 ANALYZER ON (B)(6) 2016, RESULTING AS < 0.100 MUI/ML. THIS SAMPLE WAS ALSO REPEATED ON THE CENTAUR ANALYZER, RESULTING AS < 2.0 MUI/ML. THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE HCGB REAGENT LOT NUMBER WAS 156542. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. DURING INVESTIGATIONS, IT WAS NOTED THAT THERE WERE ABNORMAL SAMPLE PROBE MOVEMENT AND ABNORMAL SAMPLE ASPIRATION ALARMS CLOSE TO THE TIME THE HIGH RESULTS WERE MEASURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16128 COBAS 6000 E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR