BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM TOTAL BHCG

    MDR report key: 897970 · Received August 16, 2007

    Report

    Report Number
    2623532-2007-00472
    Event Type
    Malfunction
    Date Received
    August 16, 2007
    Date of Event
    April 16, 2007
    Report Date
    May 7, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
    Product Code
    JHI
    PMA / PMN Number
    K935673
    Removal / Correction Number
    2623532-4/10/07-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYTICAL LABORATORY TESTING REVEALED THAT THE PRESENCE OF AGGREGATE MATERIAL IN THE B-HCG SPECIMEN DILUENT CAUSED AN INCREASE IN THE BACKGROUND OF THE SPECIMEN DILUENT, WHICH RESULTED IN AXSYM ERROR CODE 1118 AND DIFFERENCES IN CONCENTRATION VALUES WHEN THE PT SAMPLE WAS DILUTED. THE FORMATION OF THESE AGGREGATES IS SPECIFIC FOR B-HCG SPECIMEN DILUENT (9C21J) FORMULATION, WHERE AN INTERACTION OCCURS BETWEEN THE BOVINE PLASMA DIAGNOSTIC BASE (PDB) AND NORMAL GOAT SERUM (NGS). EXPERIMENT IDENTIFIED THE PRESENCE OF LGM IN THE COMPOSITION OF THE AGGREGATE MATERIAL IN THE PDB USED TO MFR THE AFFECTED B-HCG SPECIMEN DILUENTS. IT WAS DETERMINED THAT THE PDB LOTS USED IN THE SPECIMEN DILUENT PROMOTES THE FORMATION OF AGGREGATES IN THE PRESENCE OF NGS. PROTEIN AGGREGATES CONTAINING IGM WERE CONFIRMED DURING WESTERN BLOT TESTING PERFORMED ON A SAMPLE OF THE SPECIMEN DILUENT CONTAINING PDB LOT 44160X101, (SUPPLIER LOT 113). INCLUDED IN THIS STUDY WAS ANOTHER 9C21J SAMPLE CONTAINING PDB LOT 30211X100 (SUPPLIER LOT 103) WHICH ACTED AS A CONTROL WITH NO PRESENCE OF IGM, AND A THIRD 9C21J SAMPLE CONTAINING PDB LOT 22240X101, THAT CORRESPONDED WITH A PDB LOT FROM A PREVIOUS B-HCG RECALL. THE AGGREGATES MAY CLOG THE MATRIX CELL AND REACTION CELL OF THE AXSYM AND IMX ANALYZERS, RESPECTIVELY. PROTEIN AGGREGATES FOUND IN THE B-HCG SPECIMEN DILUENT MAY CAUSE A DECREASED FLOW RATE OF THE MATRIX CELL THAT CAN RESULT INCREASED BACKGROUND RATES IN THE ASSAY DUE TO RESIDUAL CONJUGATE BEING PRESENT WHEN SUBSTRATE WAS ADDED TO THE IMMUNOASSAY REACTION. THIS REDUCTION IN FLOW RATE IS ASSOCIATED WITH AXSYM ERROR CODE MESSAGE 1118 FOR WHICH SEVERAL COMPLAINTS WERE RECEIVED. THE TESTING IS CONCLUSIVE THAT THE FORMATION OF IGM PROTEIN AGGREGATES IN THE IMPLICATED LOTS OF PDB IS THE CAUSE OF THE INCREASE IN BACKGROUND FOR THE B-HCG SPECIMEN DILUENT, WHICH RESULTED IN THE INVESTIGATION OF THIS ISSUE. AS A RESULT OF THE INVESTIGATION, PDB WILL NO LONGER BE USED TO MFR B-HCG SPECIMEN DILUENT. THE PRODUCT REFORMULATION WILL CORRECT THE AGGREGATE ISSUE WHEN THE REFORMULATION IS COMPLETED AND IMPLEMENTED. PRODUCT WAS RETIRED FROM THE MARKET UNTIL A NEW B-HCG SPECIMEN DILUENT BUFFER FREE OF PDB IS IMPLEMENTED. THE REFORMULATION CONSISTS OF THE SUBSTITUTION OF PDB IN THE CURRENT SPECIMEN DILUENT. ALTERNATIVES TO PDB ARE BEING EVALUATED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AXSYM ERROR CODE 1118 (INTERCEPT TOO LOW) OCCURRED FREQUENTLY WITH B-HCG HIGH VALUE SPECIMENS WHEN THE AUTO-DILUTION PROTOCOL IS UTILIZED. THE CUSTOMER PERFORMED A MANUAL DILUTION OF THE SPECIMEN THAT PRODUCED ERROR CODE 1118 AND THE ERROR WAS NOT REPRODUCED FOR THE AXSYM B-HCG ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM TOTAL BHCG MEIA FOR MEASUREMENT OF TOTAL BHCG JHI ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. NA 48063Q100

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR AXSYM ANALYZER| LIST 07A83-01