BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1659451 · Received April 15, 2010

    Report

    Report Number
    1823260-2010-02246
    Event Type
    Malfunction
    Date Received
    April 15, 2010
    Date of Event
    March 22, 2010
    Report Date
    May 20, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. CALIBRATION AND QUALITY CONTROLS DO NOT INDICATE AN ISSUE. BASED UPON THE INFORMATION PROVIDED, A POSSIBLE REASON FOR THE EVENT WAS AN ELEVATED G-FORCE IN COMBINATION WITH LOW CENTRIFUGATION TIME. NO INSTRUMENT PERFORMANCE DATA WAS AVAILABLE FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    CALLER REPORTED AN INFORM SYSTEM BLOOD GLUCOSE RESULT OF HI, WHICH ON THE INFORM SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL, LAB RESULT OF 95 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS, REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    A PATIENT WAS ADMITTED TO THE ER WITH A SUSPECTED CARDIAC EVENT AND TROPONIN T TESTS WERE RUN SEVERAL TIMES WITH A STABLE RESULT AROUND 50 NG/L. THE NEXT DAY, (B) (6) 2010, THE TROPONIN T RESULT FROM A NEW SAMPLE WAS 393 NG/L AND WAS REPORTED TO THE WARD. THE NEXT DAY, (B) (6) 2010, THE WARD CALLED BACK TO THE LAB AND QUESTIONED THE RESULT. A NEW SAMPLE WAS DRAWN AND ANALYZED WITH A RESULT AROUND 50 NG/L. THE SAMPLE WHICH INITIALLY RECOVERED 393 NG/L WAS ANALYZED AGAIN WITH A NEW LOT NUMBER OF REAGENT AND RECOVERED AROUND 50 NG/L. THE PATIENT WAS GIVEN 500 IU FRAGMIN AS A CONSEQUENCE OF THE FALSE POSITIVE RESULT. NO OTHER TREATMENT OR MEDICATION WAS CHANGED AND THE PATIENT DID NOT COME TO ANY HARM. THE TROPONIN T REAGENT LOT NUMBER AT THE TIE OF THE INITIAL RESULT WAS 153401. THE REAGENT LOT AT THE TIME OF THE REPEAT RESULT WAS 154101.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1