BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY TOTAL BILIRUBIN ASSAY

    MDR report key: 3240189 · Received July 22, 2013

    Report

    Report Number
    1628664-2013-00178
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 12, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CIG
    PMA / PMN Number
    K060574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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).

    Additional Manufacturer Narrative · 1

    IN-HOUSE TESTING CONSISTED OF USING CLINICAL CHEMISTRY TOTAL BILIRUBIN REAGENT LOT 43053UQ11, LIST NUMBER 06L45-41, ALONG WITH BILIRUBIN CALIBRATOR LIST NUMBER 01E66-04, LOTS 13429M500 (SUSPECT LOT), 17321M500 , 21155M500, AND 25295M500. THREE ARCHITECT SYSTEMS ANALYZERS(C4000, C8000 AND C16000) WERE USED. EACH CALIBRATOR LOT WAS SUCCESSFULLY CALIBRATED ACROSS THE THREE SYSTEMS. BIO-RAD UNASSAYED LYPHOCHEK CONTROLS (LOTS 15631/15632) WERE RUN AS VALIDITY QUALITY CONTROL WITH (B)(6) RUN AS PATIENTS. A TOTAL OF (B)(6) REPLICATES PER SAMPLE WERE DISTRIBUTED EVENLY ACROSS THREE INSTRUMENTS. TESTING WAS REPEATED WITH EACH CALIBRATOR LOT. ALL RESULTS MET ACCEPTANCE CRITERIA. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT TOTAL BILIRUBIN ASSAY PACKAGE INSERT AND THE ARCHITECT SYSTEMS OPERATION MANUAL CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER CONCERN. BASED ON THE AVAILABLE DATA AND THE RESULTS OF THIS EVALUATION, A PRODUCT MALFUNCTION WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT ALLEGED FALSELY ELEVATED ARCHITECT CLINICAL CHEMISTRY TOTAL BILIRUBIN ASSAY RESULTS WERE GENERATED FOR ONE NEONATE. AN INITIAL RESULT OF 18.0 MG/DL WAS GENERATED ON AN ARCHITECT C16000 ANALYZER AND REPORTED FROM THE LAB. THE INFANT WAS TRANSFERRED TO THE NEONATAL INTENSIVE CARE UNIT (NICU) FOR OBSERVATION. THE PATHOLOGIST QUESTIONED THE RESULT. THE BILIRUBIN WAS REPEATED WITHIN THE NICU FACILITY AND GENERATED A RESULT OF 12.0 MG/DL (METHODOLOGY UNKNOWN BY THE CUSTOMER; IT IS ALSO UNKNOWN WHETHER A NEW SAMPLE WAS TAKEN FOR TESTING OR THE INITIAL SAMPLE WAS RETESTED). UPON INVESTIGATING THE ISSUE, THE LAB FOUND THE SAMPLE TO BE GROSSLY HEMOLYZED AND ICTERIC. PREVIOUS RESULTS FOR THIS INFANT WERE: 9.7, 9.8, 12.0, 17.0 AND 18.0 MG/DL. CONTROLS HAVE BEEN WITHIN SPECIFICATIONS AND NO INSTRUMENT ISSUES HAVE BEEN DISCOVERED. THERE ARE NO ISSUES WITH ANY OTHER ASSAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341092 CLINICAL CHEMISTRY TOTAL BILIRUBIN ASSAY CIG ABBOTT MANUFACTURING INC 43689UQ03

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C16000 LN:03L77-01, SN:(B)(4)| ARCHITECT CLIN CHEM BILIRUBIN CALIBRATOR| ARCHITECT C16000 LN:03L77-01, SN: (B)(4)| LN: 01E66-04, LOT: 13429M500