BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2399502 · Received January 5, 2012

    Report

    Report Number
    1823260-2012-00109
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Date of Event
    December 12, 2011
    Report Date
    January 5, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCGB) RESULTS ON THEIR COBAS E601 ANALYZER DURING (B)(6). THE CUSTOMER HAD THREE QUESTIONABLE RESULTS, BUT ONLY PROVIDED DATA FOR TWO PATIENTS WITH DISCREPANT RESULTS. ALL TESTS WERE PERFORMED ON THE SAME ANALYZER. THE FIRST PATIENT'S INITIAL HCGB RESULT WAS 0.4 MIU/ML. THE SAMPLE WAS REPEATED AND THE RESULT WAS 1100 MIU/ML. THE SECOND REPEAT RESULT WAS 900 MIU/ML WHICH WAS THOUGHT TO BE ACCURATE. 900 MIU/ML WAS REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER STATED THESE RESULTS ARE NOT THE EXACT RESULTS; THEY ARE ONLY ESTIMATES OF WHAT THE RESULTS WERE AT THE TIME. ON (B)(6) 2011, THE SECOND PATIENT, A (B)(6) FEMALE, HAD AN INITIAL HCGB RESULT OF 0.267 MIU/ML. THE CUSTOMER DISCUSSED THE PATIENT WITH THE ER DOCTOR AND REPEATED THE TEST BECAUSE THE PATIENT WAS PREGNANT. THE FIRST REPEAT RESULT WAS 10000 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:100 AND THE REPEAT RESULT WAS 101168 MIU/ML. THERE WERE NO ADVERSE EVENTS. THE HCGB REAGENT LOT NUMBER WAS 16250103 AND THE EXPIRATION DATE WAS 07/31/2012. THE FIELD SERVICE REPRESENTATIVE FOUND A DROP HANGING ON END OF THE REAGENT PROBE. IT LOOKED LIKE THE CUSTOMER HAD AIR IN THE WATER. THE MAIN WATER SYSTEM FOR THE COBAS 6000 WAS JUST REPLACED. HE PERFORMED MECHANICAL CHECKS. THE INSTRUMENT RAN FINE AND WITHIN SPECIFICATIONS. THE CUSTOMER CALIBRATED AND RAN QUALITY CONTROL WITH PASSING RESULTS. THE CUSTOMER RAN A PRECISION TEST THAT RAN FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1