BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 1803014 · Received August 17, 2010

    Report

    Report Number
    1823260-2010-04881
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 31, 2010
    Report Date
    December 3, 2010
    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

    A ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED FOR INVESTIGATION. NO FURTHER EVENTS HAVE BEEN REPORTED SINCE THE REPLACEMENT OF THE MEASURING CELL. THE FALSELY HIGH RESULTS WERE NOT REPORTED OUTSIDE OF THE LAB.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN THE (B)(6).

    Description of Event or Problem · 1

    I WAS DUPED BY A LOCAL CHIROPRACTOR THAT HAD ADVERTISED IN OUR LOCAL NEWSPAPER ABOUT THE DRX9000. AFTER 10TH TREATMENTS, I WASN'T GETTING ANY BETTER AND BY THE 20TH TREATMENT, I HAD TO GO TO THE LOCAL REHAB TREATMENT CENTER BECAUSE EVERY STEP I TOOK WAS EXTREME PAIN. UP TO THIS DAY, I STILL HAVE A PROBLEM LAYING DOWN AND SITTING FOR A LITTLE WHILE WHICH I NEVER HAD A PROBLEM WITH BEFORE THE TREATMENTS WITH THE SRX9000. THE MACHINE I THINK IS JUST A MODERN VERSION OF A MEDIVAL TORTURE DEVICE. DATES OF USE: (B)(6) 2009. DIAGNOSIS OR REASON FOR USE: PINCHED NERVE - CHIROPRACTOR DIAGNOSIS.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE HIGH HCG (HUMAN CHORIONIC GONADOTROPIN) RESULTS FOR 20 TO 50 SAMPLES PER MONTH WHICH RESULTED LOWER UPON REPEAT TESTING. THE USER PROVIDED DATA FOR TWO PATIENT SAMPLES. PATIENT SAMPLE 1 INITIAL RESULT WAS 4.56 MIU/ML WITH A DATA FLAG. THE REPEAT RESULT WAS < 0.100 MIU/ML WITH A DATA FLAG. ON (B)(6) 2010, PATIENT SAMPLE 2 INITIAL RESULT WAS 1.64 MIU/ML WITH A DATA FLAG. THE REPEAT RESULT WAS < 0.100 MIU/ML WITH A DATA FLAG. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE DISCREPANCIES. THE HCG REAGENT LOT NUMBER WAS 157397.

    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