BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY CARBON DIOXIDE

    MDR report key: 3122759 · Received May 21, 2013

    Report

    Report Number
    1628664-2013-00137
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    KHS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4). AN EVALUATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE HISTORICAL COMPLAINTS, REVIEW OF HISTORICAL DATA, REVIEW OF DESIGN HISTORY RECORDS, REVIEW OF LABELING AND PERFORMANCE TESTING. HISTORICAL COMPLAINT, DATA AND DESIGN RECORD REVIEWS DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. AN INVESTIGATION WAS PERFORMED USING CLINICAL CHEMISTRY CARBON DIOXIDE REAGENT, LN 3L80-21, LOT NUMBER 42524UQ06. THE ASSAY WAS CALIBRATED AND BIO-RAD LYPHOCHEK LEVEL 1 AND LEVEL 2 QUALITY CONTROL MATERIAL WAS RUN ON A C4000, C8000 AND C16000. ALL QC REPLICATES WERE WITHIN THE ESTABLISHED MEANS. CONTROL MATERIAL AND A SERUM POOL WERE RUN ON EACH ANALYZER FOR A TOTAL OF EIGHTEEN REPLICATES OF EACH TESTING MATERIAL. ALL CONTROL MATERIAL REPLICATES WERE WITHIN ESTABLISHED MEAN RANGES AND SERUM POOL MATERIAL REPLICATES WERE WITHIN THE MEAN ADULT REFERENCE RANGE ACCORDING TO THE CLINICAL CHEMISTRY CARBON DIOXIDE PACKAGE INSERT, COMMODITY # 304387/R1, NOVEMBER 2009. NO DISCREPANT RESULTS OR A QC OUT OF RANGE OCCURRED DURING THIS STUDY. BASED ON THE DATA AVAILABLE AND THE RESULTS OF THIS EVALUATION, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER EXPERIENCED 7 PATIENTS WITH DISCREPANT CO2 RESULTS ON THE ARCHITECT C16000 ANALYZER. THE FOLLOWING INFORMATION WAS PROVIDED: INITIAL DATA RANGED FROM 29.7 TO 31.4 MEQ/L; TEST SID'S WERE BETWEEN 801-809 (UNABLE TO CONFIRM CORRESPONDENCE OF THE DATA TO THE SAMPLE ID); RETEST READINGS WERE IN THE RANGE 20.0-26.7 MEQ/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. NO FURTHER PATIENT DETAILS OR DATA WAS ABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224915 CLINICAL CHEMISTRY CARBON DIOXIDE KHS ABBOTT MANUFACTURING INC 42524UQ06

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C16000 ANALYZER| LN 03L77-01 SN (B)(4)| ARCHITECT C16000 ANALYZER| LN 03L77-01 SN (B)(4)