BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 2211714 · Received August 15, 2011

    Report

    Report Number
    1823260-2011-04354
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    August 1, 2011
    Report Date
    November 18, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHI
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THE CALIBRATION AND QUALITY CONTROL WERE ACCEPTABLE. THE CUSTOMER DID NOT USE THE RECOMMENDED RACK ADAPTERS ON EITHER INSTRUMENT WHICH MIGHT CAUSE THE LOW RESULT.

    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 RESULTS FOR INTACT HUMAN CHORIONIC GONADOTROPIN + THE B-SUBUNIT (HCG+B) ON THEIR COBAS E601. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT WITH DISCREPANT RESULTS REPORTED OUTSIDE THE LABORATORY. THE EMERGENCY ROOM QUESTIONED THE PATIENT'S RESULT AS THEY COULD HEAR THE BABY'S HEARTBEAT AND ASKED FOR A REPEAT TEST AND PROVIDED A SECOND BLOOD DRAW. REPEAT TESTING WAS PERFORMED ON THE ORIGINAL E601 (E601) AND ON A COBAS E411 (E411) RACK ANALYZER (SERIAL NUMBER (B)(4)). THE REPEAT TESTING ON THE E411 WAS FOR HUMAN CHORIONIC GONADOTROPIN, STAT (HCGSTAT). THE PATIENT'S SAMPLE WAS TESTED ON THE E601 AND THE RESULT WAS 0.435 MIU/ML. THE SAMPLE WAS THEN TESTED ON THE E411 AND THE RESULT WAS 2.61 MIU/ML. THE SAMPLE WAS REPEATED ON THE E411 AND THE RESULT WAS 10000 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:100 AND REPEATED ON THE E411 WITH A RESULT OF 126268 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS THEN RETESTED ON THE E601 WITH A RESULT OF 10000 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:100 AND THE RESULT WAS 118781 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SECOND BLOOD DRAW WAS TESTED ON THE E601 AND THE RESULT WAS 10000 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:100 AND THE RESULT WAS 111902 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SECOND BLOOD DRAW WAS THEN TESTED ON THE E411 AND THE RESULT WAS 10000 MIU/ML ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS DILUTED 1:100 AND THE RESULT WAS 122897 MIU/ML ACCOMPANIED BY A DATA FLAG. ALL RESULTS WERE REPORTED. THERE WERE NO ADVERSE AFFECTS TO THE PATIENT AS A RESULT OF THIS EVENT. THE HCG+B REAGENT'S LOT NUMBER WAS 16015003 AND THE EXPIRATION DATE WAS 1/31/2012. THE CUSTOMER DECLINED A SERVICE VISIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 032 YR DEMULEN| TEGRETOL TABLET| LIPITOR| PAXIL TABLET| T-STAT 2% PADS