BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG QUALITATIVE II REAGENT KIT

    MDR report key: 18789500 · Received February 27, 2024

    Report

    Report Number
    3008344661-2024-00025
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    January 23, 2024
    Report Date
    April 15, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    PMA / PMN Number
    P110029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE INFORMATION FOR SECTION A1 - PATIENT IDENTIFIER: SID (B)(6). ALL AVAILABLE PATIENT INFORMATION IS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P10-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P10-21/-31. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SEE MFR# 3008344661-2024-00018-00 FOR INITIAL SUBMISSION ON ALNTY I HBS AG QUAL CON, 08P11-22, 54084FN00. SEE MFR# 3008344661-2024-00019-00 FOR INITIAL SUBMISSION ON ALNTY I HBSAG QUAL 1200, 08P10-32.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE ALINITY I HBSAG QUALITATIVE II RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD TESTING REVIEW. THE TICKET TRENDING REVIEW OF AT LEAST 12 MONTHS COMPLAINT DATA FOR THE LIKELY CAUSE LIST NUMBERS DID NOT IDENTIFY ANY TREND REGARDING COMMONALITIES FOR COMPLAINT LOTS AND ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LOT NUMBERS AND THE CUSTOMER¿S ISSUE. HISTORICAL PERFORMANCE IN THE FIELD OF REAGENT LOTS USING WORLDWIDE DATA WAS EVALUATED. THE PATIENT MEDIAN RESULT FOR THE LOTS IS COMPARABLE WITH ALL OTHER LOTS IN THE FIELD AND WITHIN ESTABLISHED BASELINES, CONFIRMING NO SYSTEMIC ISSUE FOR THE PRODUCT LOTS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I HBSAG QUALITATIVE II REAGENT FOR LOT NUMBERS 55638FN00 AND 57450FN00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE RESULTS FOR ALINITY I HBSAG QUALITATIVE II AND ALINITY I HBSAG QUALITATIVE II CONFIRMATORY FOR ONE PATIENT. THE ALINITY I HBSAG QUALITATIVE II TEST WAS REPEATED WITH DIFFERENT SAMPLES FROM THE SAME PATIENT AND THE RESULTS WERE NONREACTIVE. THE ORIGINAL SAMPLE WAS REPEATED ON ANOTHER ALINITY WITH REACTIVE RESULTS. THE FOLLOWING DATA WAS PROVIDED: ORIGINAL DRAW WAS ON (B)(6) 2024 WITH THREE TUBES: SID (B)(6) (REACTIVE RESULTS), SID (B)(6) (NONREACTIVE RESULTS) SID (B)(6) (NONREACTIVE RESULTS). SID (B)(6) PROCESSED INITIAL RESULTS ON (B)(6) 2024 ON ALINITY SERIAL NUMBER (B)(6): HBSAG = 950.7; CONFIRMATORY = HBSAGQUAC1 = 1.54 S/CO HBSAGQUAC2 = 788.91 S/CO HBSAGQUA%N = 100 % NEUTRALIZATION. SID (B)(6) REPEAT RESULTS ON (B)(6) 2024 ON ALINITY SERIAL NUMBER (B)(6): HBSAG = 1951. SID (B)(6) PROCESSED ON (B)(6) 2024 ON ALINITY SERIAL NUMBER (B)(6): HBSAG = 0.46. SID (B)(6) PROCESSED ON (B)(6) 2024 ON ALINITY SERIAL NUMBER (B)(6): HBSAG = 0.27. NEW DRAW ON (B)(6) 2024 SID (B)(6) PROCESSED ON ALINITY SERIAL NUMBER (B)(6): HBSAG = 0.29. ADDITIONAL DATA PROVIDED 13FEB2024; SID (B)(6) WAS PROCESSED WITH A NEW REAGENT LOT 57450FN00 AND RESULT WAS POSITIVE. SID (B)(6) WHICH WAS NEGATIVE IS NOW POSITIVE WITH THE NEW REAGENT LOT NUMBER 57450FN00. SID (B)(6) IS STILL NEGATIVE WITH THE NEW LOT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE RESULTS FOR ALINITY I HBSAG QUALITATIVE II AND ALINITY I HBSAG QUALITATIVE II CONFIRMATORY FOR ONE PATIENT. THE ALINITY I HBSAG QUALITATIVE II TEST WAS REPEATED WITH DIFFERENT SAMPLES FROM THE SAME PATIENT AND THE RESULTS WERE NONREACTIVE. THE ORIGINAL SAMPLE WAS REPEATED ON ANOTHER ALINITY WITH REACTIVE RESULTS. THE FOLLOWING DATA WAS PROVIDED: ORIGINAL DRAW WAS ON (B)(6) 2024 WITH THREE TUBES: SID (B)(6)(REACTIVE RESULTS), SID (B)(6)(NONREACTIVE RESULTS) SID (B)(6)(NONREACTIVE RESULTS). SID (B)(6) PROCESSED INITIAL RESULTS ON (B)(6) 2024 ON ON ALINITY SERIAL NUMBER (B)(6): HBSAG = 950.7. CONFIRMATORY = HBSAGQUAC1 = 1.54 S/CO HBSAGQUAC2 = 788.91 S/CO HBSAGQUA%N = 100 % NEUTRALIZATION. SID (B)(6) REPEAT RESULTS ON (B)(6) 2024 ON ALINITY SERIAL NUMBER (B)(6): HBSAG = 1951. SID (B)(6) PROCESSED ON (B)(6) 2024 ON ALINITY SERIAL NUMBER (B)(6): HBSAG = 0.46. SID (B)(6) PROCESSED ON (B)(6) 2024 ON ALINITY SERIAL NUMBER (B)(6): HBSAG = 0.27 NEW DRAW ON (B)(6) 2024 SID (B)(6) PROCESSED ON ALINITY SERIAL NUMBER (B)(6): HBSAG = 0.29. ADDITIONAL DATA PROVIDED 13FEB2024; SID (B)(6) WAS PROCESSED WITH A NEW REAGENT LOT 57450FN00 AND RESULT WAS POSITIVE. SID (B)(6) WHICH WAS NEGATIVE IS NOW POSITIVE WITH THE NEW REAGENT LOT NUMBER 57450FN00. SID (B)(6) IS STILL NEGATIVE WITH THE NEW LOT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668645 ALINITY I HBSAG QUALITATIVE II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 57450FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I HBS AG QUAL CON, 08P11-22, 54084FN00| ALNTY I HBS AG QUAL CON, 08P11-22, 54084FN00| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)