BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HBSAG

    MDR report key: 4110165 · Received September 23, 2014

    Report

    Report Number
    3002809144-2014-00176
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    June 25, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ABBOTT GERMANY
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ON OCTOBER 23, 2014 IT WAS IDENTIFIED THAT: THE INCORRECT MANUFACTURING LOCATION WAS DOCUMENTED IN THIS MANUFACTURER REPORT. THE REPORT SHOULD HAVE INDICATED IT WAS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 03A47, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06D19, WHICH HAS A DIFFERENT MANUFACTURING LOCATION. A NEW MANUFACTURER REPORT (NUMBER 1415939-2014-00235) HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER. AN EVALUATION IS IN-PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) RESULTS WHILE USING THE PRISM (B)(4) ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING DATA FOR THE (B)(6) YEAR OLD MALE DONOR: (B)(6) 2014: (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) AT THE AGE OF 12. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590336 PRISM HBSAG HBSAG KSJ ABBOTT GERMANY 37107LI00

    Patients

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