BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY

    MDR report key: 6070195 · Received November 1, 2016

    Report

    Report Number
    3008344661-2016-00067
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Report Date
    May 30, 2017
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THE DEVICE DID NOT PERFORM AS INTENDED. HOWEVER, NO SYSTEMATIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, SPECIFICITY TESTING, AND A REVIEW OF LABELING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CAUSED THE CUSTOMER ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO PATIENT SAMPLES WERE AVAILABLE FOR RETURN, AND CLINICAL SPECIFICITY TESTING OF PANELS USING IN-HOUSE RETAINED KITS OF THE LIKELY CAUSE LOT STORED AT THE RECOMMENDED STORAGE CONDITION WAS PERFORMED. SPECIFICITY TESTING MET ALL SPECIFICATIONS. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS COMPLAINT INVESTIGATION, THE ASSAY PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT LIST (B)(4)THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT LIST 2G23, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P54. PATIENT INFORMATION. PATIENT IDENTIFIER FOR BOTH PATIENTS, SID (B)(6). INITIAL REPORTER: ADDRESS INFORMATION ADDRESS: (B)(6). AN EVALUATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) PATIENT RESULTS GENERATED WHILE USING THE ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY REAGENTS. THE FOLLOWING DATA WAS PROVIDED. SID ) (B)(6) ARCHITECT (B)(6) QUALITATIVE RESULTS, INITIAL (B)(6), REPEAT AFTER CENTRIFUGATION (B)(6). ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY, CONFIRMATION TEST (B)(6) (NO SPECIFIC VALUES PROVIDED). PCR METHOD SHOWED (B)(6) RESULTS. OTHER METHODS SHOWED (B)(6) ), (NO VALUES SPECIFIC VALUES WERE PROVIDED FOR (B)(6)). SID (B)(6). ARCHITECT (B)(6) QUALITATIVE RESULTS, INITIAL 1.2 (REACTIVE), REPEAT AFTER CENTRIFUGATION 1.58 (REACTIVE). ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY, CONFIRMATION (B)(6) (NO SPECIFIC VALUES PROVIDED). PCR METHOD SHOWED (B)(6) RESULTS. OTHER METHODS SHOWED (B)(6) RESULT WAS (B)(6) , AND (B)(6) (NO VALUES PROVIDED). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721152 ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY HBSAG CONFIRMATORY KSJ ABBOTT IRELAND 61291FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR LN (B)(4) SN (B)(4)| LN (B)(4) LN (B)(4)