BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARAMAX ANALYTICAL SYSTEM

    MDR report key: 76551 · Received March 12, 1997

    Report

    Report Number
    2023780-1997-00001
    Event Type
    Malfunction
    Date Received
    March 12, 1997
    Date of Event
    February 21, 1997
    Report Date
    March 12, 1997
    Manufacturer
    DADE INTL. INC.
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EXTREMELY ELEVATED NBIL (NEONATAL BILIRUBIN) VALUES WERE OBTAINED ON A PT SAMPLE. TESTING RESULTS FROM A NEW SAMPLE WERE ELEVATED BUT WITHIN THE EXPECTED RANGE. NO CHANGE IN PT TREATMENT WAS TAKEN BASED ON THESE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARAMAX ANALYTICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJC DADE INTL. INC. 7 20 ZX *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DAY