BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CX-7

    MDR report key: 88960 · Received February 15, 1995

    Report

    Report Number
    88960
    Event Type
    Injury
    Date Received
    February 15, 1995
    Date of Event
    November 17, 1994
    Report Date
    November 23, 1994
    Manufacturer
    BECKMAN INSTRUMENTS, INC.
    Product Code
    JJC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    PT PHOSPHORUS REPORTED <1.0 MG/DL SINCE 11/9/94. REPORT FLAGGED AS "RESULTS SUPPRESSED" OIR INDICATING A LOW VALUE. ON 11/11/94 SAMPLE WAS MANUALLY DILUTED AND RESULT ACTUALLY WAS 8.7 MG/DL. SAMPLE WAS SENT TO ANOTHER LAB AND RESULTS WERE VERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CX-7 CHEMISTRY ANALYZER JJC BECKMAN INSTRUMENTS, INC. CX-7 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| L