BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HCV

    MDR report key: 1880644 · Received October 25, 2010

    Report

    Report Number
    1415939-2010-00522
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    July 20, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION - COMPLAINT AND FIELD DATA REVIEW. THE COMPLAINT WAS REGARDING DISCREPANT RESULTS OBSERVED WHEN USING ABBOTT PRISM HCV REAGENT KIT (LIST NUMBER 06D18-68) LOT NUMBER 84553M500. SEVERAL SAMPLES FROM A SERIES OF DONATIONS FROM TWO DONORS WERE TESTED WITH PRISM HCV, RIBA, AND HCV RNA. SEPARATE ALIQUOTS OF THESE SAMPLES WERE ALSO TESTED AT A FACILITY IN (B)(6) WITH ANOTHER PRISM HCV REAGENT LOT AND WITH ABBOTT ARCHITECT HCV. NONE OF THE SAMPLES WERE AVAILABLE FOR USE IN THIS INVESTIGATION. RESULTS OF THE INVESTIGATION INDICATED THAT PRISM HCV REAGENT LOT 84553M500 IS PERFORMING ACCORDING TO PRODUCT LABEL CLAIMS. REVIEW OF THE TEST RESULTS PROVIDED INDICATED THAT THE DISCREPANCIES OBSERVED FOR EACH OF THE FOUR SAMPLES ((B)(4)) BETWEEN THE TWO PRISM HCV REAGENT LOTS WERE GREATER THAN WHAT WOULD BE EXPECTED FROM NORMAL LOT TO LOT VARIABILITY FOR THIS ASSAY. TESTING AT THE ACCOUNT FACILITY GENERATED NONREACTIVE SAMPLE TO CUTOFF VALUES (S/CO) FOR THESE FOUR SAMPLES, WHILE TESTING BY THE EUROPEAN REFERENCE LABORATORY WITH THE OTHER PRISM HCV REAGENT LOT GENERATED STRONG REACTIVE S/CO VALUES. NONREACTIVE S/CO VALUES RANGED FROM 0.03 TO 0.92, AND THE REACTIVE S/CO VALUES RANGED FROM 1.24 TO 2.82 FOR THESE 4 SAMPLES. TESTING WAS PERFORMED ON SEPARATE ALIQUOTS FROM THE SAME DONATION. THE WIDE RANGE OF S/CO VALUES GENERATED SUGGESTS ANOTHER SOURCE OF THE DISCREPANCIES, SUCH AS SAMPLE MIX-UP, LABELING ERROR, OR OTHER SAMPLE HANDLING ISSUE. SENSITIVITY OF PRISM HCV REAGENT LOT 84553M500 WAS EVALUATED THROUGH REVIEW OF FIELD DATA FOR METRICS WHICH ARE INDICATORS OF ASSAY SENSITIVITY: POSITIVE CALIBRATOR SAMPLE TO CUTOFF (P/CO) AND POSITIVE CALIBRATOR TO NEGATIVE CALIBRATOR RATIO (P/N). THIS DATA REVIEW INDICATES PRISM HCV REAGENT LOT 84553M500 IS PERFORMING WITHIN THE SENSITIVITY REQUIREMENTS OF THIS ASSAY. FURTHER EVALUATION OF THIS REAGENT LOT WAS NOT PERFORMED AS THE LOT HAD EXPIRED ON (B)(6), 2010, WHICH WAS PRIOR TO RECEIPT OF THIS COMPLAINT. COMPLAINT RECORDS WERE ALSO REVIEWED TO DETERMINE IF OTHER PRISM HCV CUSTOMERS HAD EXPERIENCED SIMILAR ISSUES THAT MAY REQUIRE FURTHER INVESTIGATION. NO OTHER COMPLAINTS FOR PRISM HCV REAGENT LOT 84553M500 RELATED TO THE ISSUE OBSERVED AT THE CUSTOMER FACILITY WERE IDENTIFIED. IN SUMMARY, RESULTS OF THIS INVESTIGATION INDICATE THAT PRISM HCV REAGENT KIT LOT 84553M500 IS MEETING PRODUCT LABEL CLAIMS. THE DISCREPANCY IN RESULTS OBSERVED FOR SAMPLE (B)(6) BETWEEN THE PRISM HCV ASSAY, WHICH GENERATED NONREACTIVE RESULTS, AND THE ARCHITECT HCV ASSAY, WHICH GENERATED (B)(6) RESULTS, MAY BE ATTRIBUTED TO DIFFERENT ASSAY FORMATS, DIFFERENT RECOMBINANT ANTIGENS, AND DIFFERENT LENGTHS OF RECOMBINANT HCV GENOME ENCODED ANTIGENS. DIFFERENCES IN ASSAY FORMAT AND IN THE ANTIGENS USED FOR ANTIBODY DETECTION CAN RESULT IN DIFFERENCES IN SENSITIVITY. HOWEVER, SAMPLE MIX-UP, LABELING ERROR, OR OTHER SAMPLE HANDLING ISSUE COULD ALSO BE THE SOURCE OF THE DISCREPANT RESULTS OBSERVED WITH THIS SAMPLE. PER THE PRISM HCV PACKAGE INSERT INTERPRETATION OF RESULTS SECTION, ALTHOUGH THE ASSOCIATION OF INFECTIVITY OF DONATED BLOOD OR PLASMA AND THE PRESENCE OF ANTI-HCV IS STRONG, IT IS RECOGNIZED THAT PRESENTLY AVAILABLE METHODS FOR ANTI-HCV DETECTION ARE NOT SENSITIVE ENOUGH TO DETECT ALL POTENTIALLY INFECTIOUS UNITS OF BLOOD, PLASMA, OR POSSIBLE CASES OF HCV INFECTION. A NONREACTIVE TEST RESULT DOES NOT EXCLUDE INFECTION. RETURNS WERE NOT AVAILABLE. CUSTOMER DID NOT HAVE SUFFICIENT VOLUME OF THE SAMPLES AVAILABLE FOR RETURN. FILE KITS WERE NOT EVALUATED AS THE LOT HAD EXPIRED ON 8/28/2010, AND FIELD DATA RELATED TO THE QUALITY ISSUE WAS AVAILABLE FOR REVIEW.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED (B)(6) ON DONOR SAMPLES THAT TESTED (B)(6). SEVERAL SPECIMENS WERE TESTED FOR EACH DONOR SHOWING SEROCONVERSION OVER A PERIOD OF TIME. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. DATA PROVIDED: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISM HCV IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF ANTIBODIES TO HEPATITIS C VIRUS MZO ABBOTT LABORATORIES 84553M500

    Patients

    Seq Age Sex Outcome Treatment
    1 PRISM LIST 6A36-04, SERIAL (B)(4)| PRISM LIST 6A36-04, SERIAL (B)(4)