BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2470671 · Received February 28, 2012

    Report

    Report Number
    1823260-2012-01115
    Event Type
    Malfunction
    Date Received
    February 28, 2012
    Date of Event
    February 1, 2012
    Report Date
    May 17, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE ISSUES IDENTIFIED PREVIOUSLY WITH THE MEASURING CELL WERE NOT THE REASON FOR THIS EVENT. CALIBRATION AND QUALITY CONTROL DATA DO NOT INDICATE A GENERAL REAGENT ISSUE. THERE WAS NO EVIDENCE FOR AN INSTRUMENT RELATED PROBLEM. THE CUSTOMER WAS NOT FOLLOWING THE TUBE MANUFACTURER'S SPECIFICATIONS FOR CENTRIFUGATION TIME. THE CUSTOMER WAS NOT USING THE RECOMMENDED RACK ADAPTORS FOR THE PRIMARY TUBES.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCGB) RESULTS ON THEIR E601 ANALYZER. THE CUSTOMER PROVIDED DATA FOR TWO PATIENTS WITH DISCREPANT RESULTS REPORTED OUTSIDE THE LABORATORY. BOTH SAMPLES WERE REPEATED AFTER THE RESULTS WERE QUESTIONED USING THE ORIGINAL E601 ANALYZER. THE FIRST PATIENT'S INITIAL HCGB RESULT WAS 0.409 MIU/ML. ON (B)(6) 2012, THE FIRST PATIENT'S REPEAT HCGB RESULT WAS 10000 MIU/ML ACCOMPANIED BY A DATA FLAG. IT WAS REPEATED AND THE RESULT WAS 193159 MIU/ML ACCOMPANIED BY A DATA FLAG. ON (B)(6) 2012, THE SECOND PATIENT'S INITIAL HCGB RESULT WAS 0.414 MIU/ML. ON (B)(6) 2012, THE SECOND PATIENT'S REPEAT HCGB RESULT WAS 10000 MIU/ML ACCOMPANIED BY A DATA FLAG. IT WAS REPEATED AND THE RESULT WAS 19611 MIU/ML ACCOMPANIED BY A DATA FLAG. THE CUSTOMER CONSIDERED THE REPEAT RESULTS TO BE CORRECT. IT IS UNKNOWN IF THERE WERE ANY ADVERSE EVENTS. THE HCGB REAGENT LOT NUMBER WAS 16250103 AND THE EXPIRATION DATE WAS 07/31/2012. ON (B)(6) 2012, THE FIELD SERVICE REPRESENTATIVE (FSR) COULD NOT DETERMINE THE CAUSE OF THE EVENT. HE RAN PERFORMANCE TESTING AND MEASURING CELL TWO FAILED. ON (B)(6) 2012, THE FSR SUSPECTED A DIRTY REAGENT PROBE WAS THE CAUSE OF THE EVENT. HE FLUSHED OUT THE REAGENT PROBE WITH SYSWASH FOLLOWED BY A FLUSH WITH DI WATER. HE RAN PERFORMANCE TESTING. THE 1ST CALIBRATION HIGH FAILED. ON (B)(6) 2012, THE FSR SUSPECTED THE PERFORMANCE TESTING FAILED BECAUSE OF A BUBBLE. HE RAN PERFORMANCE TESTING WHICH PASSED WITH NO ERRORS. HE RETURNED THE SYSTEM BACK TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER CEM ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1