BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HCV

    MDR report key: 1212615 · Received October 29, 2008

    Report

    Report Number
    1415939-2008-00509
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    September 19, 2008
    Report Date
    October 2, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION TEAM RECEIVED THE SAMPLE RETURNED FOR USE IN THE INVESTIGATION. THE INVESTIGATION INCLUDED TESTING OF THE SAMPLE WITH ABBOTT (B)(4) EIA 2.0 (LIST NUMBER 4A14); WHICH WAS NONREACTIVE. IN ADDITION, THE ACCOUNT PROVIDED A CHIRON RIBA RESULT THAT WAS NEGATIVE FOR THE SAMPLE. RESULTS OF THIS TESTING INDICATE THAT THIS SAMPLE IS NONREACTIVE FOR ANTIBODIES TO HCV. THE SAMPLE WAS ALSO TESTED WITH (B)(6) VIRUS TEST, VERSION 2.0 (B)(4) NAT, AND WAS NEGATIVE. THE INVESTIGATION TEAM ALSO REVIEWED THE COMPLAINT RECORDS FOR PRISM (B)(4) LIST 6D18. THE INVESTIGATION TEAM DID NOT IDENTIFY ANY SIMILAR OR RELATED ISSUES IN THE REVIEWS. FROM THIS INVESTIGATION, IT CAN BE CONCLUDED THAT PRISM (B)(4) REAGENT KIT LOTS 65105M100 AND 65108M100 ARE PERFORMING ACCORDING TO PRODUCT LABEL CLAIMS. THE INVESTIGATION TEAM CANNOT PROVIDE THE ACCOUNT WITH A SPECIFIC REASON FOR THE REPEATEDLY REACTIVE RESULTS THAT WERE OBSERVED WITH THE SAMPLE; HOWEVER, DISCREPANCIES IN INDIVIDUAL DONOR RESULTS CAN OCCUR AND INDICATE POSSIBLE NON-SPECIFIC REACTIVITY WITH PRISM (B)(4). PER THE PRISM (B)(4) PACKAGE INSERT ((B)(4), SUMMARY AND EXPLANATION OF THE TEST, RESULTS (INTERPRETATION OF RESULTS), AND LIMITATIONS OF THE PROCEDURE SECTIONS), THE PRISM (B)(4) ASSAY MAY YIELD NONSPECIFIC REACTIVITY. FALSE-REACTIVE TEST RESULTS HAVE BEEN OBSERVED DUE TO NONSPECIFIC INTERACTIONS. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT NOT YET INITIATED. COMPLAINT INVESTIGATION RETURNS (SAMPLES) ARE AVAILABLE FROM THE CUSTOMER, AND WERE REQUESTED, BUT HAVE NOT YET BEEN RECEIVED. A DEVICE EVALUATION HAS NOT YET BEEN COMPLETED; THEREFORE, THERE ARE NO RESULTS TO REPORT, AND NO RESULTS ARE AVAILABLE TO SUPPORT A CONCLUSION. 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 A FALSELY REACTIVE PRISM HCV RESULT ON A DONOR SPECIMEN. INITIALLY, THE SPECIMEN TESTED PRISM HCV NEGATIVE. LATER, THE SPECIMEN WAS RETRIEVED FROM STORAGE, AND USED FOR PERFORMANCE TESTING AFTER SERVICE WAS PERFORMED ON THE PRISM ANALYZER. DURING PERFORMANCE TESTING, THE SPECIMEN GENERATED REPEATEDLY REACTIVE PRISM HCV RESULTS. THE DONOR UNIT WAS DESTROYED, DUE TO THE REACTIVE PRISM HCV RESULTS. ANOTHER SPECIMEN FROM THE SAME DONOR WAS SENT FOR CONFIRMATION TESTING. CONFIRMATION TESTING GENERATED A RIBA NEGATIVE RESULT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    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 65105M100

    Patients

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