BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II

    MDR report key: 4123035 · Received September 26, 2014

    Report

    Report Number
    3008344661-2014-00036
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    July 16, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. DEVICE (B)(4). NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. AN EVALUATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND SENSITIVITY TESTING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. TESTING WAS COMPLETED USING A RETAINED KIT OF THE MOST RECENTLY EXPIRED LOT 38100LF00 (EXPIRED (B)(6) 2014). CLINICAL SENSITIVITY TESTING OF SEROCONVERSION PANELS MET ALL SPECIFICATIONS INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. TESTING OF THE RETURN PATIENT SAMPLE (B)(4) WAS ALSO PERFORMED WITH EXPIRED REAGENT LOT 38100LF00, AS USED IN THE CUSTOMER'S LABORATORY AND WITH AN ADDITIONAL REFERENCE IN DATE (B)(4) REAGENT LOT 45032LF00 AND THE CUSTOMER'S OBSERVATION WAS REPEATED AS NON-REACTIVE RESULTS OF 0.26 AND 0.21 S/CO WERE GENERATED RESPECTIVELY. THEREFORE, ADDITIONAL REFERENCE TESTING WAS PERFORMED AND NON-REACTIVE RESULTS WERE GENERATED FOR BOTH ALTERNATE ARCHITECT HBSAG ASSAY LIST 6C36 AND AXSYM CORE LIST 7A41. THE ADDITIONAL HBV MARKER TESTING WAS PERFORMED IN THIS CASE AND THE ASSESSMENT OF THE PROFILE FOR THIS PATIENT INDICATES A TRUE NEGATIVE FOR HBSAG. TAKING INTO CONSIDERATION THE TEST RESULT PROFILE FOR THE PATIENT SAMPLE, IT IS LIKELY THAT THE HBV NAT TEST IS POSSIBLY FALSE REACTIVE AND THERE WAS NON-SPECIFIC REACTIVITY ON BIORAD HBSAG ULTRA. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION, THE ASSAYS PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. SEE ALSO MANUFACTURING REPORT 3008344661-2014-00038 AND 3008344661-2014-00037 FOR THE SAME ISSUE DOCUMENTING THE DIFFERENT SUSPECT MEDICAL DEVICE LOT NUMBERS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) RESULTS ON THE ARCHITECT I2000 ANALYZER. THE PATIENT IS A (B)(6) MALE BLOOD DONOR, WITH 7 DONATIONS SINCE 2009; VACCINATED FOR (B)(6) AT (B)(6). THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2014 SID (B)(4). (B)(4) 2014 (B)(4). THE PATIENT WAS FOUND REACTIVE ON ANOTHER METHOD. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601122 ARCHITECT HBSAG QUALITATIVE II HBSAG KSJ ABBOTT IRELAND 38100LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR LN 08C89-01 SN (B)(4)| ARCHITECT I2000 ANALYZER| ARCHITECT I2000 ANALYZER| LN 08C89-01 SN (B)(4)