BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HBSAG

    MDR report key: 4251582 · Received November 14, 2014

    Report

    Report Number
    1415939-2014-00235
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    February 26, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 03A47, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06D19. ON OCTOBER 23, 2014: THIS ISSUE WAS PREVIOUSLY REPORTED UNDER MDR NUMBER 3002809144-2014-00176. THE INCORRECT MANUFACTURING LOCATION WAS DOCUMENTED IN THAT REPORT. THIS REPORT WAS GENERATED TO DOCUMENT (B)(4) AS THE MANUFACTURE LOCATION. EVALUATION: FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, BATCH RECORD REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETURN MATERIAL WAS TESTED AND GENERATED (B)(6) RESULTS USING THE PRISM HBSAG, ARCHITECT (B)(6) ASSAY, ARCHITECT (B)(6) QUALITATIVE II ASSAY AND AXSYM (B)(6) ASSAY, THIS TESTING REPEATED THE CUSTOMERS RESULTS. A SENSITIVITY TESTING PROTOCOL WAS EXECUTED USING LOT 37107LI00; TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. SEROCONVERSION PANELS WERE TESTED AND COMPARED TO THE PRISM HBSAG RESULTS, BASED ON THESE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF THE LOT IS NOT ADVERSELY AFFECTED. NO ISSUES WERE IDENTIFIED FROM THE BATCH RECORD REVIEW WHICH WOULD INDICATE A PRODUCT DEFICIENCY. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION A DEFICIENCY OF THE PRISM HBSAG REAGENT LIST NUMBER 03A47, LOT 37107LI00, WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) RESULTS WHILE USING THE PRISM HBSAG ASSAY.THE CUSTOMER PROVIDED THE FOLLOWING DATA FOR THE (B)(6) MALE DONOR:ON (B)(6) 2014: PRISM (B)(6) RESULT OF 0.33 S/CO (B)(6). THIS DONOR GENERATED (B)(6) RESULTS USING THE NAT AND BIORAD ELISA METHODS. IT WAS DOCUMENTED THAT THE DONOR WAS VACCINATED FOR(B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736244 PRISM HBSAG HBSAG KSJ ABBOTT LABORATORIES 37107LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR PRISM 6 CHANNEL ANALYZER| LN 06A36-04, SN (B)(4)