BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHIRON DIAGNOSTICS EXPRESS REACTION CUVETTES

    MDR report key: 66930 · Received February 1, 1997

    Report

    Report Number
    1519113-1997-00001
    Event Type
    Malfunction
    Date Received
    February 1, 1997
    Date of Event
    January 10, 1997
    Report Date
    January 31, 1997
    Manufacturer
    CHIRON DIAGNOSTICS CORP.
    Product Code
    JRI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A HOLE IN THE BOTTOM OF THE REACTION CUVETTES ALLOWED THE REAGENT/PT SAMPLE TO LEAK OUT OF THE BOTTOM OF THE CUVETTE, CAUSING NEGATIVE RESULTS. THE LAB DID NOT REPORT OUT ANY PT RESULTS. LAB PERSONNEL CALLED CO FIELD SERVICE PERSONNEL TO INVESTIGATE. THERE WAS NO SERIOUS INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHIRON DIAGNOSTICS EXPRESS REACTION CUVETTES EXPRESS MODEL 550/560 REACTION CUVETTES JRI CHIRON DIAGNOSTICS CORP. NA 1363 & 1369

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other