BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 1901037 · Received November 17, 2010

    Report

    Report Number
    1823260-2010-06786
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 11, 2010
    Report Date
    January 26, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED CONCERNING THE EVENT. THE INITIAL RESULT ON (B)(6) 2010 WAS 0.709 MIU/ML. THE REPEAT RESULT ON (B)(6) 2010 WAS 0.188 MIU/ML AND REPEAT RESULTS ON (B)(6) 2010 WERE 123.8 AND 117.8 MIU/ML. THE PATIENT'S STATUS WAS INCORRECTLY DIAGNOSED AS NON-PREGNANT. THE PATIENT'S STATUS WAS THEN DECLARED AS "4 WEEKS GESTATION" BASED ON THE RESULTS FROM THE OTHER LABORATORY. INFORMATION PROVIDED STATES THE PATIENT WAS HARMED PSYCHOLOGICALLY BY THIS EVENT. NO SPECIFIC DETAILS WERE PROVIDED TO FURTHER CLARIFY THE PSYCHOLOGICAL HARM ALLEGED.

    Additional Manufacturer Narrative · 1

    INSUFFICIENT INFORMATION WAS PROVIDED FOR FURTHER INVESTIGATION OF THIS EVENT. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER EXPERIENCED AN ISSUE OF QUESTIONABLE RESULTS FOR INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCG) ONGOING SINCE (B)(6) 2010. OF THE INFORMATION FOR TWO SAMPLES PROVIDED, ONE SAMPLE WAS DISCREPANT. THE SAMPLE WAS TESTED TWICE WITH NEGATIVE RESULTS. NO SPECIFIC DATA WERE PROVIDED. ON (B)(6) 2010, THE PATIENT WAS CONFIRMED AS (B)(6) PREGNANT WHEN SHE WAS TESTED AT ANOTHER HOSPITAL USING AN ABBOTT ANALYZER AND AT THIS LABORATORY WITH THE MIN VIDAS AND RAPID CARD. NO SPECIFIC DATA WERE PROVIDED. ON (B)(6) 2010 THE ORIGINAL SAMPLE WAS RETESTED ON THE COBAS E411 AND A POSITIVE RESULT WAS RECEIVED. NO SPECIFIC DATA WERE PROVIDED. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE EVENT. THE LOT NUMBER OF THE HCG REAGENT WAS 157397.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY PROCEDURE, THE DEVICE WOULD NOT STAPLE. THE STAPLES WOULD COME OUT, HOWEVER, NOT STAPLE INTO THE SKIN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 024 YR