BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYER RAPID POINT 400

    MDR report key: 399338 · Received June 10, 2002

    Report

    Report Number
    MW1025292
    Event Type
    Malfunction
    Date Received
    June 10, 2002
    Date of Event
    May 23, 2002
    Report Date
    May 31, 2002
    Manufacturer
    BAYER CORP
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BAYER RAPID POINT INSTRUMENT REVEALED A FAILURE OF THE PAO2 PARAMETER. THIS PARAMETER FAILED BOTH THE LEVEL ONE AND LEVEL TWO QUALITY CONTROL ANALYSIS. THE MEASUREMENT CARTRIDGE BEARING EXPIRATION DATE OF 9/02 WAS REPLACED. A NEW MEASUREMENT CARTRIDGE BEARING A DIFFERENT SERIAL NUMBER WAS THEN INSTALLED. A QUALITY CONTROL ANALYSIS WAS SUCCESSFULLY COMPLETED. THE NEXT DAY A SECOND BAYER RAPID POINT INSTRUMENT BEARING THE EXPIRATION DATE OF 10/02 REVEALED A FAILURE OF THE PH PARAMETER. THE FOLLOWING PARAMETERS REVEALED FAILURES WITHIN 4 HRS: PAO2 AND PCO2. THIS INSTRUMENT IS HOUSED IN A ROOM WHICH IS CURRENTLY CLOSED AS A RESULT OF LOW CASE VOLUME. THIS INSTRUMENT IS HOWEVER BEING MAINTAINED AS A BACK UP INSTRUMENT. THE CHEMISTRY LAB SUPV WAS NOTIFIED OF THE INSTRUMENT'S FAILURE TO SATISFY QUALITY CONTROL ANALYSIS ON THE CORRESPONDING DAYS OF FAILURE. SHE CONTACTED THE TECH SUPPORT DEPT AT BAYER. QUALITY CONTROL DATA FROM EACH INSTRUMENT WAS DOWNLOADED AND FORWARDED TO THE CO. REPLACEMENT MEASUREMENT CARTRIDGES WERE RECEIVED AS REPLACEMENTS FROM BAYER. FOUR DAYS LATER THE SALES REP AND A TECHNICAL SUPPORT REP INSPECTED BOTH INSTRUMENTS AND REPLACED THE INVENTORY DISCARDED. THE SALES REP NOTIFIED THE HOSP PERFUSION AND LAB STAFF OF A LOT OF MEASUREMENT CARTRIDGES WITH A "PAO2 FAILURE". A DIVISION WITHIN THE CORP WAS AWARE OF THE FAILURE AND FAILED TO COMMUNICATE THE FAILURE. THEREFORE, A RECALL WAS NOT INITIATED. DURING THIS TIME, IT IS IMPORTANT TO NOTE THAT THERE WERE NO SCHEDULED OR EMERGENT CASES PERFORMED IN EITHER ROOM. THERE WAS NO PT IMPACT. THE CO REPLACED THE CARTRIDGES AT NO CHARGE. THE INVENTORY WAS INSPECTED FOR CARTRIDGES BEARING THE SAME LOT NUMBERS. NONE WERE FOUND. WHEN QUESTIONED REP STATED THAT PT RESULTS PRIOR TO THE NOTED FAILURES WERE INDEED ACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAYER RAPID POINT 400 POINT OF CARE CHL BAYER CORP * *
    2 BAYER RAPID POINT 400 POINT OF CARE CHL BAYER CORP * *
    3 BAYER RAPID POINT 400 POINT OF CARE CHL BAYER CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA