BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY AST-ACTIVATED

    MDR report key: 1102043 · Received August 7, 2008

    Report

    Report Number
    2018433-2008-00149
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 1, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    CIF
    PMA / PMN Number
    K071525
    Removal / Correction Number
    2018433-08/07/08-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROGRESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4), CONCOMITANT MEDICAL PRODUCTS: ARCHITECT C8000 ANALYZER, LIST# 01G06-01/01G06-11, ARCHITECT C16000, LIST# 03L77-01. A-AST REAGENT LOTS, LIST 08L91/20 AND 08L91-40 MANUFACTURING AND EXPIRATION DATES: 59035HW00, MANUFACTURED 12/3/2007, EXPIRATION DATE: 11/30/2008. 61031HW00, MANUFACTURED 1/24/2008, EXPIRATION DATE: 1/31/2009. 64052HW00, MANUFACTURED 5/23/2008, EXPIRATION DATE: 5/7/2009. 57017HW00, MANUFACTURED 9/20/2007, EXPIRATION DATE: 8/10/2008. 59031HW00, MANUFACTURED 12/3/2007, EXPIRATION DATE: 11/30/2008. 61038HW00, MANUFACTURED 1/24/2008, EXPIRATION DATE: 1/31/2009. 64050HW00, MANUFACTURED 5/9/2008, EXPIRATION DATE: 5/7/2009. AN ABBOTT CUSTOMER REPORTED A FALSE CLINICAL CHEMISTRY ACTIVATED ASPARTATE AMINOTRANSFERASE (A-AST) RESULT GENERATED ON A PATIENT SAMPLE. THE PATIENT SAMPLE TESTED GENERATED RESULTS OF 19.0 AND 21.2 IU/L AND NO ERROR OR RESULT WERE GENERATED FOR THIS PATIENT SAMPLE. AFTER A-AST TESTING WAS COMPLETED, ACTIVATED ALANINE AMINOTRANSFERASE (A-ALT) TESTING WAS PERFORMED ON THE SAME PATIENT SAMPLE, WHERE A RESULT OF 1895 IU/L WAS GENERATED. DUE TO THE ELEVATED ALT RESULT, THE CUSTOMER DILUTED THE PATIENT SERUM 1:20 AND RE-ASSAYED FOR A-AST AND A RESULT OF 4103 IU/L WAS OBTAINED. THE ORIGINAL LOWER A-AST RESULTS WERE ERRONEOUS DUE TO SUBSTRATE DEPLETION. THERE WAS NO ERROR CODES OR RESULT FLAG INDICATING THE INCORRECT PATIENT RESULT WAS DUE TO SUBSTRATE DEPLETION. ALL CUSTOMER CONTROLS WERE IN RANGE AT THE TIME OF THE INCIDENT. INVESTIGATION TESTING INDICATED THE A-AST ASSAY WITH THE CURRENT PARAMETERS GENERATED RESULTS THAT WERE FLAGGED WITH RATE LINEARITY (RL) % OR ERROR CODE 1053 (UNABLE TO CALCULATE) AND ALSO GENERATED LOW RESULTS WITH NO ERROR CODE FOR THE SAMPLE WITH AN EXPECTED CONCENTRATION OF APPROXIMATELY 4000 U/L. THE SAME SAMPLES RUN WITH THE ADJUSTED PARAMETERS, CORRECTED RESULTS BELOW AND WITHIN THE FLEX RANGE WITH UP TO 500 MG/DL LIPEMIA INTERFERENCE. THEREFORE, REGARDLESS OF THE A-AST AND A-ALT RESULTS GENERATED WITH THE CURRENT PARAMETERS, ALL SAMPLES GENERATED ACCURATE RESULTS WHEN ASSAYED WITH THE COLOR CORRECTION AND INCREASED ABSORBANCE LIMIT. INVESTIGATION TESTING DEMONSTRATED BY ADDING COLOR CORRECTION PARAMETERS AND INCREASING THE LOWER ABSORBANCE LIMIT OF THE A-AST AND A-ALT ASSAYS, ACCURATE RESULTS ARE GENERATED WHEN ASSAYING SAMPLES WITH HIGH A-AST CONCENTRATIONS. COLOR CORRECTION PARAMETER CHANGES WERE IMPLEMENTED INTO THE CLINICAL CHEMISTRY A-AST PACKAGE INSERT, RELEASED (B)(4) 2008. ADDITIONALLY, A PRODUCT CORRECTION LETTER WAS ISSUED ON (B)(4) 2008 TO ABBOTT CUSTOMERS TO INFORM THEM SOME SAMPLES MAY GENERATED A-AST RESULTS OF <5 U/L OR RESULTS WITHIN REFERENCE RANGES WHEN THE ACTUAL CONCENTRATION EXCEEDS THE NON-FLEX LINEARITY OF 1985 U/L, AND/OR ERROR CODE 1053 OR RL% FLAGS MAY BE GENERATED. THE LETTER PROVIDED INSTRUCTIONS FOR IMPLEMENTING THE NEW COLOR CORRECTION PARAMETERS. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE ABBOTT CLINICAL CHEMISTRY ACTIVATED ASPARTATE AMINOTRANSFERASE (AST) ASSAY IS USED FOR THE QUANTITATION OF ASPARTATE AMINOTRANSFERASE IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS NOT DISTRIBUTED IN THE UNITED STATES. THERE IS THE POTENTIAL TO GENERATE FALSELY DECREASED VALUES FOR AST WHEN THE LEVEL IS VERY HIGH. AST IS PART OF A PANEL OF BLOOD MARKERS THAT IS USED IN THE DIAGNOSIS OF LIVER DISEASE. THESE OTHER MARKERS WILL ALERT THE PHYSICIAN TO THE DIAGNOSIS OF LIVER INJURY. THE FALSELY DEPRESSED RESULT WILL NOT BE IN AGREEMENT WITH THE OTHER MARKERS AND CAN POTENTIALLY CAUSE A MINOR DELAY IN THE DIAGNOSIS OF LIVER INJURY, BUT WILL NOT RESULT IN ANY SIGNIFICANT PATIENT HARM. A PRODUCT CORRECTION WAS ISSUED AND REPORTED UNDER 21CFR806 TO THE FDA ON AUGUST 7, 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY AST-ACTIVATED QUANTITATION OF ASPARTATE AMINOTRANSFERASE CIF ABBOTT MANUFACTURING, INC. NA 57028HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LIST# 08L91-40. LOT# 57017HW00, EXP DATE: 8/10/08| LIST# 08L91-40, LOT# 59031HW00, EXP DATE: 11/30/08| CLINICAL CHEMISTRY AST-ACTIVATED REAGENTS| AEROSET ANALYZER, LIST# 09D05-01| ARCHITECT C8000 ANALYZER, LIST# 01G06-01/01G06-11| LIST# 08L91-20, LOT# 61031HW00, EXP DATE : 1/31/09| LIST# 08L91-40, LOT# 64050HW00, EXP DATE: 5/7/09| LIST# 08L91-40, LOT# 61038HW00, EXP DATE: 1/31/09| ARCHITECT C16000, LIST# 03L77-01| LIST# 08L91-20, LOT# 64052HW00, EXP DATE: 5/7/09| LIST# 08L91-20, LOT# 59035HW00, EXP DATE: 11/30/08