BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT HTLV-I/HTLV-II EIA

    MDR report key: 1191723 · Received October 9, 2008

    Report

    Report Number
    1415939-2008-00508
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 10, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MTP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE INVESTIGATIONAL TESTING ALONG WITH A REVIEW OF COMPLAINT DATA DETERMINED THAT A PRODUCT DEFICIENCY IS NOT LIKELY. ACCEPTANCE CRITERIA WERE MET FOR THE COMPLAINT TRACKING AND TRENDING REVIEW. PATIENT DISCREPANT RESULT TESTING OF FILE KIT MATERIAL INDICATED THAT THE RESULTS OF THE TESTING WERE INCONCLUSIVE. THE RETURNED PATIENT SPECIMEN WAS FOUND TO BE REPEATEDLY REACTIVE USING LOTS 63508M100 AND 63413M201. FURTHER TESTING OF THE PATIENT SAMPLE BY (B)(6) LABORATORIES PRODUCED NEGATIVE RESULTS INDICATING THAT THE ISSUE OBSERVED BY THE CUSTOMER WAS REPRODUCED WHEN TESTED WITH ABBOTT HTLV-I/HTLV-II EIA. THE ISSUE OF SPECIMENS THAT ARE INITIALLY AND REPEATEDLY REACTIVE AND NEGATIVE OR INDETERMINATE ON SUPPLEMENTAL TESTING IS ADDRESSED IN THE ABBOTT HTLV-I/HTLV-II EIA PACKAGE INSERT. THE INTERPRETATION OF RESULTS SECTION OF THE PACKAGE INSERT STATES: "IN MOST SETTINGS IT IS APPROPRIATE TO INVESTIGATE REPEATEDLY REACTIVE SPECIMENS BY ADDITIONAL MORE SPECIFIC TESTS." ADDITIONALLY, IT STATES: "THE INTERPRETATION OF RESULTS OF SPECIMENS FOUND REPEATEDLY REACTIVE BY EIA AND NEGATIVE OR INDETERMINATE ON ADDITIONAL TESTING IS UNCLEAR; FURTHER CLARIFICATION MAY BE OBTAINED BY TESTING ANOTHER SPECIMEN FROM THE SAME PATIENT TAKEN THREE TO SIX MONTHS LATER." THE INVESTIGATION TEAM EVALUATED THE RETURNED PATIENT SPECIMEN USING LOTS 63413M201 AND 63508M100 FROM ABBOTT LABORATORIES INVENTORY, AND THE SPECIMENS WERE FOUND TO BE REPEATEDLY REACTIVE WITH BOTH LOTS OF MATERIAL. FURTHER EVALUATION WAS PERFORMED, AND THE SPECIMEN WAS FOUND TO BE NEGATIVE WITH AN ALTERNATE METHODOLOGY. COMPLAINT DATA WAS REVIEWED TO DETERMINE IF OTHER CUSTOMERS HAD EXPERIENCED SIMILAR ISSUES THAT MIGHT WARRANT FURTHER INVESTIGATION. THIS REVIEW DID NOT SHOW ANY UNUSUAL ACTIVITY RELATED TO THE CUSTOMER OBSERVATIONS. IN SUMMARY, INVESTIGATION TESTING AND RECORDS REVIEW INDICATE THAT THE PRODUCT IS PERFORMING ACCEPTABLY. THE ISSUE OBSERVED IN THIS INVESTIGATION IS ADDRESSED IN THE ABBOTT HTLV-I/HTLV-II EIA PACKAGE INSERT. THE INTERPRETATION OF RESULTS SECTION OF THE PACKAGE INSERT STATES: "IN MOST SETTINGS IT IS APPROPRIATE TO INVESTIGATE REPEATEDLY REACTIVE SPECIMENS BY ADDITIONAL MORE SPECIFIC TESTS." ADDITIONALLY, IT STATES: "THE INTERPRETATION OF RESULTS OF SPECIMENS FOUND REPEATEDLY REACTIVE BY EIA AND NEGATIVE OR INDETERMINATE ON ADDITIONAL TESTING IS UNCLEAR; FURTHER CLARIFICATION MAY BE OBTAINED BY TESTING ANOTHER SPECIMEN FROM THE SAME PATIENT TAKEN THREE TO SIX MONTHS LATER." THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION AND CONCLUSION CODES CANNOT BE DETERMINED, INVESTIGATION IS IN PROCESS. 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 GENERATED REPEATEDLY REACTIVE HTLV-I/II EIA RESULTS FROM AN ORGAN DONOR ON LIFE SUPPORT. THE SAMPLE USED FOR TESTING WAS A CADAVERIC SPECIMEN WHICH TESTED HTLV NEGATIVE AT A REFERENCE LABORATORY THE SPECIMEN WAS REPEATED AT THE ACCOUNT AGAIN GENERATING REPEATEDLY REACTIVE HTLV-I/II EIA RESULTS. THE PROCEDURE TO HARVEST THE ORGANS FOR DONATION WAS STOPPED. NO ORGANS WERE RELEASED FROM THE ACCOUNT. CSS DISCUSSED THE HTLV-I/II EIA PACKAGE INSERT STATEMENTS THAT CADAVERIC SAMPLE TESTING HAS NOT BEEN ESTABLISHED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. DATA: INITIAL HTLV-I/II EIA, LOT 63413M201, CUTOFF = 0.287, DONOR = 0.456, 0.555, 0.568 (REACTIVE). REPEAT HTLV-I/II EIA, LOT 63508M100, CUTOFF = 0.404, DONOR = 0.666, 0.577, 0.439 (REACTIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT HTLV-I/HTLV-II EIA FOR THE DETECTION OF HTLV-I/ HTLV-II ANTIBODIES IN HUMAN SERUM OR PLASMA MTP ABBOTT LABORATORIES NA 63413M201

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR QUANTUM LIST 3303-86, SERIAL (B)(4)| QUANTUM LIST 3303-86, SERIAL (B)(4)