BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE

    MDR report key: 2862801 · Received December 10, 2012

    Report

    Report Number
    3005094123-2012-00061
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 30, 2012
    Manufacturer
    A.I.D.D LONGFORD
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LN 01P97, ARCH HBSAG QUALITATIVE THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., LN 01L80, ARCH HBSAG. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER INDICATED THE PATIENT WAS ON WARFARIN. PER THE 1P97 PACKAGE INSERT, LIQUID ANTICOAGULANTS MAY HAVE A DILUTION EFFECT RESULTING IN LOWER CONCENTRATIONS FOR INDIVIDUAL PATIENT SPECIMENS. WARFARIN IS AN ANTICOAGULANT WHICH MAY HAVE HAD AN EFFECT IN LOWERING THE CONCENTRATION OF THE 1P97 RESULT. FROM THE COMPLAINT TEXT IT CAN BE NOTED THAT THE NEGATIVE RESULTS OBTAINED WERE HIGH NEGATIVE RESULTS. TRACKING AND TRENDING IDENTIFIED NO ADVERSE TREND FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER CONSISTENTLY GENERATED (B)(6) RESULTS FOR ONE PATIENT SAMPLE. THE PATIENT GENERATED (B)(6) RESULTS ON ANOTHER ARCHITECT I2000SR, ON A PRISM ANALYZER, AND USING NAT TESTING. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT HBSAG QUALITATIVE KSJ A.I.D.D LONGFORD 20125LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR LN 03M74-01 SN (B)(4)| ARCH I2000SR LN 03M74-01 SN (B)(4)