BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYER - TECHNICON IMMUNO-1

    MDR report key: 302750 · Received October 27, 2000

    Report

    Report Number
    MW1020297
    Event Type
    Malfunction
    Date Received
    October 27, 2000
    Report Date
    October 27, 2000
    Manufacturer
    BAYER CORP.
    Product Code
    JJF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HOSP HAS DISCOVERED A FLAW IN ONE OF ITS LAB ANALYZERS THAT COULD POTENTIALLY CAUSE SIGNIFICANT HARM TO PTS. HOSP HAS CONTACTED THE MFR WITH CONCERNS, HOWEVER IT IS RPTR'S IMPRESSION THAT THEY ARE RELUCTANT TO ADMIT THAT THERE IS A PROBLEM WITH THEIR PRODUCT. HOSP HAS DEVELOPED A WORK-AROUND FOR INSTITUTION BUT RPTR IS CONCERNED THAT REPORTING ERRORS MAY OCCUR AT OTHER LABS. WHEN A SERUM SAMPLE IS ANALYZED FOR QUANTITATIVE HUMAN CHORIONIC GONADATROPIN (PREGNANCY TEST) THE INSTRUMENT MAY REPORT A RESULT AS LESS THAN 0, WHEN IN FACT THERE IS A SUBSTANTIAL AMOUNT OF THE HORMONE PRESENT. THE END RESULT OF THIS COULD BE A FALSE NEGATIVE RESULT REPORTED ON A PREGNANT PT WHO COULD SUBSEQUENTLY BE EXPOSED TO COUNTER INDICATED PROCEDURES. INSTRUMENT TRAINING AND INTERPRETATION OF THE OPERATING MANUALS INDICATE THAT A LESS THAN RESULT IS RELIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAYER - TECHNICON IMMUNO-1 CHEMISTRY IMMUNOANALYZER JJF BAYER CORP. IMMUNO 1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other