BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISM HBSAG CONFIRMATORY

    MDR report key: 3110491 · Received May 14, 2013

    Report

    Report Number
    1415939-2013-00209
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER : (B)(6). (B)(4). AN EVALUATION IS IN PROGRESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS COMPLETED IN ORDER TO INVESTIGATE THIS ISSUE. EVALUATION OF COMPLAINT DATA FOR THE LOT IN QUESTION DID NOT IDENTIFY ATYPICAL ACTIVITY. REVIEW OF THE LOT DEVICE HISTORY RECORDS DID NOT REVEAL ANY ISSUES RELATED TO THIS INCIDENT. QUALITY RECORDS WERE REVIEWED TO DETERMINE IF OTHER CUSTOMERS HAD EXPERIENCED SIMILAR ISSUES THAT MIGHT WARRANT FURTHER INVESTIGATION. THE REVIEWS DID NOT SHOW ANY UNUSUAL ACTIVITY RELATED TO THIS ISSUE. BASED ON THE EVALUATION RESULTS, NO PRODUCT DEFICIENCY OR MALFUNCTION IDENTIFIED AND THE PRODUCT IS PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED A (B)(6) RESULT FOR THE PRISM HBSAG CONFIRMATORY TEST WHEN TESTED A PATIENT SAMPLE (DONOR) FOR ANOTHER LAB WHERE THE DONOR SAMPLE HAD ALREADY BEEN TESTED REPEAT (B)(6) WITH THE PRISM HBSAG REAGENT. THE DONOR HAD ALWAYS BEEN (B)(6) FOR THIS ASSAY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213406 PRISM HBSAG CONFIRMATORY KSJ ABBOTT LABORATORIES 18045M500

    Patients

    Seq Age Sex Outcome Treatment
    1 PRISM 6 CHANNEL-CE 06A36-04 SN (B)(4)