BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALIQUOT PROBE

    MDR report key: 2956786 · Received February 7, 2013

    Report

    Report Number
    MW5028923
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    October 24, 2012
    Report Date
    November 14, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT SEEN IN ED FOR CP, SOB AND HYPERKALEMIA. ADMITTED TO 23 HR OBS AND TREATED FOR CV K OF 6.7 WITH KAYEXALATE 45 GM PO. LAB RESULT WAS INACCURATE. WHEN REPEATED AND PROBLEM IDENTIFIED THE PHYSICIAN WAS NOTIFIED AND PT RECEIVED KCL 40 MEQ PO. K REMAINED STABLE THROUGHOUT. SERVICE REP INVESTIGATED AND REPLACED ALIQUOT PROBE (SMALL TEAR IN SHEATH). BLEACHED, PRIMED AND TESTED. INSTRUMENT FUNCTION VERIFIED, QC RUN. CORRELATIONS WITH VISTA 1 (BACKUP) PERFORMED AND WITHIN LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52015 ALIQUOT PROBE ALIQUOT PROBE JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. 1500

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention VISTA DIMENSION 1500