BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY ALBUMIN BCP

    MDR report key: 1530891 · Received November 17, 2009

    Report

    Report Number
    2018433-2009-00047
    Event Type
    Malfunction
    Date Received
    November 17, 2009
    Report Date
    October 28, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    CJW
    PMA / PMN Number
    K981814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CLINICAL CHEMISTRY MULTICONSTITUENT CALIBRATOR LOT 73223M200 EXPIRATION DATE 6/30/2010. ALBUMIN P REAGENT LIST 7D54-20, LOT 78021HW00 MANUFACTURED DATE 6/30/2009. EXPIRATION DATE 6/10/2010. RESULTS OF THE SUPPLEMENTAL INVESTIGATION ARE AS FOLLOWS: THE CUSTOMERS QUALITY CONTROL (QC) VALUES FOR ALBUMIN SHIFTED LOW WITH FIRST USE OF CC MCC, LN 1E65-04, LOT 73223M200 WHILE USING CLINICAL CHEMISTRY (CC) ALBUMIN BCP (ALBP) REAGENT LOT 74003HW00 ON TWO ARCHITECT CI8200 SYSTEMS. THE CUSTOMER WAS PREVIOUSLY USING CC MCC LOT 63421M100 WITHOUT ANY ISSUE. FOR THIS INVESTIGATION, CC ALBP REAGENT LOTS 74003HW00 AND 76015HW00 WERE CALIBRATED WITH CC MCC LOTS 63421M100, 73223M200, AND 77118M200. BIO-RAD UNASSAYED LYPHOCHEK AND ASSAYED MULTIQUAL CONTROL MEAN VALUES WERE COMPARED TO EVALUATE LOT TO LOT VARIABILITY BETWEEN THE CALIBRATOR AND REAGENT LOT COMBINATIONS. TESTING WAS PERFORMED ON 3 ARCHITECT SYSTEMS. ALL CONTROL VALUES WERE WITHIN THE ESTABLISHED RANGES. IN-HOUSE TESTING DEMONSTRATED THE CONTROL VALUES FROM CC ALBP OBTAINED USING CC MCC LOT 73223M200 ARE LOWER THAN THOSE GENERATED WITH CC MCC LOT 63421M100, HOWEVER THEY ARE WITHIN ESTABLISHED RANGES. SINCE THE CONTROLS ARE WITHIN THE ACCEPTABLE RANGES, CC MCC (LN 1E65-04) LOTS 63421M100, 73223M200, AND 77118M200 AND CC ALBP REAGENT LOTS 74003HW00 AND 76015HW00 ARE PERFORMING WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY COULD BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MCC CALIBRATORS LIST 1E65-04 LOT 73223M200. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT AFTER CALIBRATING THE ARCHITECT ALBUMIN BCP REAGENT WITH THE NEW MCC CALIBRATOR LOT 73223M200, THERE WAS A DOWNWARD SHIFT IN THE CONTROL VALUES. THIS ALSO OCCURRED ON THE SECOND ARCHITECT ANALYZER. THE ACCOUNT RESOLVED THE ISSUE BY INCREASING THE CALIBRATION FACTORS. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED. THIS IS A USER REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY ALBUMIN BCP FOR THE QUANTITATION OF ALBUMIN IN HUMAN SERUM OR PLASMA CJW ABBOTT MANUFACTURING, INC. 69053HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT ANALYZER LIST 1G06-01 (B)(4)| ARCHITECT ANALYZER LIST 1G06-01 (B)(4)