BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUSZYME MONOCLONAL

    MDR report key: 1063578 · Received June 19, 2008

    Report

    Report Number
    1415939-2008-00079
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    KSJ
    Removal / Correction Number
    1415939-6/12/08-005-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 PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). SUSPECT MEDICAL DEVICE, OTHER: LOT 64425M101 IS A SUBLOT OF 64425M100 WITH THE SAME EXPIRATION DATE OF 10/9/2008, HOWEVER, THE DEVICE MANUFACTURE DATE FOR LOT 64425M101 WAS 5/12/2008. EVALUATION METHOD: STATISTICAL ANALYSIS OF HISTORICAL DATA FROM LOT 64425M100. TEST METHOD HAS POOR CAPABILITY. ABBOTT AUSZYME MONOCLONAL ENZYME IMMUNOASSAY (EIA) IS A THIRD GENERATION ASSAY FOR THE DETECTION OF HEPATITIS B SURFACE ANTIGEN IN HUMAN SERUM, PLASMA OR CADAVERIC SERUM SPECIMENS. ON 5/31/08, AUSZYME MONOCLONAL EIA MASTER LOT 64425M100 STABILITY TESTING RESULTS USING PROCEDURE C (SHORTEST INCUBATION TIME), DID NOT MEET THE DOUBLE SAMPLING PLAN ACCEPTANCE SPECIFICATION FOR THE ZERO NON-REACTIVE REPLICATES FOR THE AD SENSITIVITY REFERENCE PANEL. THE AD SENSITIVITY REFERENCE PANEL IS USED TO MIMIC THE FDA REFERENCE PANEL. STABILITY TESTING IS PERFORMED ON EACH OF FOUR DIFFERENT ASSAY PROCEDURES (A, B, C, AND D). THE ASSAY PROCEDURES DIFFER BY THE TIME AND TEMPERATURE OF THE INCUBATION STEPS, CALCULATION OF THE ASSAY CUTOFF, AND ASSAY VALIDITY SPECIFICATIONS. A SWAP OUT STUDY WAS PERFORMED TO DETERMINE IF THE DECREASED SENSITIVITY PANEL SAMPLE TO CUTOFF (S/CO) VALUES WERE DUE TO A LOSS IN POTENCY FOR THE FILLED CONJUGATE, CONJUGATE CONCENTRATE, CONJUGATE DILUENT OR BEAD. THE RESULTS OF THE STUDY DEMONSTRATED THE CONJUGATE CONCENTRATE MET SPECIFICATIONS FOR SENSITIVITY WHEN FRESHLY SPIKED INTO CONJUGATE DILUENT, BUT NOT AS FILLED CONJUGATE FOR PRODUCT FOR SALE. A CAPABILITY ANALYSIS WAS PERFORMED ON THE AUSZYME MONOCLONAL EIA STABILITY TEST METHOD, SPECIFICALLY FOR AD SENSITIVITY REFERENCE PANEL S/CO USING PROCEDURE C. THE CALCULATED CPK FOR THE AD SENSITIVITY REFERENCE PANEL USING PROCEDURE C IS 0.777, AND THE TARGET IS 1.33, THEREFORE, THE AUSZYME MASTER LOT STABILITY TEST METHOD IS NOT CAPABLE. ADDITIONALLY, A REVIEW OF THE TESTING DOCUMENT HISTORY DETERMINED THE DOUBLE SAMPLING PLAN WAS IMPLEMENTED WITHOUT AN ASSESSMENT OF TEST METHOD CAPABILITY TO DETERMINE IF THE MEET THE NEW REQUIREMENTS OF THE DOUBLE SAMPLING PLAN. THE STABILITY SAMPLING PLAN WAS IMPLEMENTED TO ALIGN WITH PROCEDURES OUTLINED IN OPERATING PROCEDURES (OP) OP.M481, ON-MARKET AND INTERNAL MEASUREMENT STANDARDS STABILITY PROCEDURES. THE AUSZYME MONOCLONAL EIA AD SENSITIVITY PANEL S/CO DATA WAS ANALYZED FOR MASTER LOT 64425M100 AND ALL OTHER LOTS PLACED ON STABILITY. THE DATA INDICATED THE MEAN AD SENSITIVITY REFERENCE PANEL S/CO FOR LOT 64425M100 WAS 1.27, AND THE MEAN FOR ALL OTHER LOTS WAS 1.61. SINCE THE MEAN OF THE DISTRIBUTION WAS CLOSER TO THE CUTOFF, A LARGE PORTION OF THE DISTRIBUTION WAS BELOW THE CUTOFF. ADDITIONALLY, REVIEW OF MASTER LOT IN-PROCESS (1-P) TESTING OF AD SENSITIVITY PANELS DETERMINED THAT LOT 64425M100 PASSED NEAR SPECIFICATION, BUT HAD LESS AD SENSITIVITY THAN OTHER MASTER LOTS TESTED. THE ROOT CAUSE FOR THE FAILING STABILITY TESTING RESULTS WAS DUE TO AN INCAPABLE STABILITY TEST METHOD. A PRODUCT INFORMATION LETTER WAS SENT TO ABBOTT CUSTOMERS IN JANUARY 2008 INFORMING THE CUSTOMER OF THE AUSZYME MONOCLONAL EIA PRODUCT DISCONTINUATION IN JUNE 2008. ON JUNE 12, 2008, A PRODUCT CORRECTION LETTER WAS SENT TO ABBOTT CUSTOMERS PROVIDING INSTRUCTIONS TO DISCONTINUE USING PROCEDURES A, C AND D, AND POINTING TO PROCEDURE B FOR CONTINUED USE WITH AUSZYME MONOCLONAL EIA MASTER LOT 64425M100 AND SUBLOT 64425M101. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    ABBOTT HAS OBSERVED NON-REACTIVE VALUES FOR LOW LEVEL REACTIVE SAMPLES DURING IN-HOUSE TESTING USING THE AUSZYME MONOCLONAL ENZYME IMMUNOASSAY (EIA), INCUBATION PROCEDURE C (38 TO 41 DEGREES C FOR 75 TO 80 MINUTES) FOR LIST 01980-71, LOT 64425M100. RESULTS GENERATED USING INCUBATION PROCEDURE A (38 TO 41 DEGREES C FOR 3 HOURS +/- 10 MINUTES) AND INCUBATION PROCEDURE D (38 TO 41 DEGREES C FOR 2 HOURS +/- 10 MINUTES) ARE WITHIN RANGE BUT LOWER THAN EXPECTED, INDICATING INCUBATION PROCEDURES A AND D MAY BE IMPACTED. AS A PRECAUTIONARY MEASURE, THE CUSTOMER COMMUNICATION INSTRUCTED THE CUSTOMER TO USE INCUBATION PROCEDURE B ONLY (15-30 DEGREES C FOR 12 TO 20 HOURS). AN INVESTIGATION FOR THE ISSUE IS ON-GOING.

    Description of Event or Problem · 1

    THE REPORTER STATED THE HAPTIC OF A BAUSCH & LOMB LENS WAS BENT, DUE TO THE INJECTOR. THERE WAS NO PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUSZYME MONOCLONAL IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF HEPATITIS B SURFACE ANTIGENS KSJ ABBOTT LABORATORIES NA 64425M100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA