BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY

    MDR report key: 9213990 · Received October 21, 2019

    Report

    Report Number
    3008344661-2019-00124
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    October 2, 2019
    Report Date
    December 3, 2019
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER'S DEVICE ANALYSIS RESULTS INCLUDE BOTH LIKELY CAUSES: ARCHITECT HBSAG QUALITATIVE II, LIST 02G22-25, LOT 02357FN00 AND ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY, LIST 02G23-25, LOT 01542FN00. EACH LIST NUMBER WILL HAVE A SEPARATE SUBMISSION, SEE MANUFACTURER REPORT NUMBER 3008344661-2019-00130 A REVIEW OF TICKETS WAS PERFORMED FOR REAGENT LOT NUMBERS 02357FN00 AND 01542FN00. THE TICKET SEARCH DETERMINED THAT THERE IS NORMAL COMPLAINT ACTIVITY FOR BOTH LIKELY CAUSE LOTS. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TESTING OF NEGATIVE PANELS WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 01542FN00, ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY ASSAY, AND SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. FIELD DATA WAS USED TO EVALUATE THE PERFORMANCE OF THE ARCHITECT HBSAG II ASSAY. THE NUMBER OF STANDARD DEVIATIONS TO THE CUTOFF FOR THE NEGATIVE POPULATION TESTED SHOWED LOT 02357FN00 IS WITHIN THE ESTABLISHED LIMITS. REVIEW OF THE MEDIAN PATIENT RESULTS BY REAGENT LOT REPORT SHOWED NO ATYPICAL PERFORMANCE FOR LOT 02357FN00. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT HBSAG QUALITATIVE II ASSAY, LOT 02357FN00 OR THE ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY ASSAY, LOT 01542FN00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER (B)(4) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER (B)(4). NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A (B)(6) ARCHITECT HBSAG QUALITATIVE II RESULT FOR 1 SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2019, SID (B)(4), INITIAL (B)(6) RESULT = (B)(6), REPEAT = (B)(6), (B)(6). HBSAG CONFIRMATORY ASSAY RESULT = (B)(6) THE PHYSICIAN QUESTIONED THE RESULT AS OTHER (B)(6) PARAMETERS WERE (B)(6). (B)(6) REPEATED = (B)(6), (B)(6) CONFIRMATORY ASSAY WAS REPEATED = % NOT APPLICABLE (NOT CONFIRMED) THE SPECIMEN WAS REPEATED IN TRIPLICATE AT NUH FOR THE SCREENING AND %NEUTRALIZATION CONFIRMATORY. THE SCREENING RESULTS WERE ALL (B)(6) AND THE CONFIRMATORY WAS INVALID. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007283 ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY HBSAG CONFIRMATORY KSJ ABBOTT IRELAND 01542FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR PROCESSING MODULE, LIST 03M74-02.| ARCHITECT I2000SR PROCESSING MODULE, LIST 03M74-02.| LIST 02G22-25, LOT 02357FN00.| SERIAL (B)(4), ARCHITECT HBSAG II.| SERIAL (B)(4).