BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S HIV AG/AB COMBO REAGENT KIT

    MDR report key: 16747130 · Received April 14, 2023

    Report

    Report Number
    3002809144-2023-00192
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    March 1, 2023
    Report Date
    June 23, 2023
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    UDI-DI
    00380740117184
    PMA / PMN Number
    BL 125679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1 - PATIENT IDENTIFIER: (B)(6) (COMPLETE SAMPLE ID). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    EVALUATION OF COMPLAINT DATA FOR ALINITY S HIV AG/AB COMBO REAGENT LOT 45152BE00 DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE COMPLAINT ISSUE. TRENDING DATA WAS REVIEWED, AND NO RELATED TRENDS WERE IDENTIFIED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. THE PERFORMANCE OF LOT 45152BE00 WAS INVESTIGATED BY COMPLETING A DEVICE HISTORY RECORD REVIEW AND DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES AND DEVIATIONS RELATED TO THE REAGENT LOT AND COMPLAINT ISSUE. A TECHNICAL REVIEW OF FIELD DATA FOR ALINITY S HIV AG/AB COMBO WAS PERFORMED. OVERALL REACTIVE RATES OF LOT 45152BE00 AT INNOVATIVE BLOOD RESOURCES INC (IBR), USA., APPLICABLE PEER SITES AND ACROSS A WHOLE BLOOD AND PLASMA SCREENING MONITORING GROUP WERE COLLECTED AND ASSESSED. ACROSS THE WHOLE BLOOD AND PLASMA MONITORING GROUP, THE CUSTOMER AND THEIR PEER SITES, THE PERFORMANCE FOR LOT 45152BE00 IS WITHIN PRODUCT REQUIREMENTS AND COMPARABLE TO OTHER LOTS ANALYZED IN THE COMPARISON. BASED ON THE INVESTIGATION, ALINITY S HIV AG/AB COMBO, REAGENT LOT 45152BE00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN INCREASE IN INITIAL REACTIVE AND REPEAT REACTIVE RESULTS WHEN USING THE ALINITY S HIV AG/AB COMBO ASSAY FOR THE MONTH OF MARCH 2023. THE FOLLOWING SID AND REAGENT LOT NUMBER AFFECTED THAT GENERATED REPEAT REACTIVE RESULTS ON THE ALINITY S SYSTEM, BUT TESTED NEGATIVE ON THE CUSTOMER¿S CONFIRMATORY BIO-RAD GEENIUS HIV 1 / 2 ASSAY (ACTUAL VALUES WERE NOT PROVIDED). LOT 45152BE00, W045023012926. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN INCREASE IN INITIAL REACTIVE AND REPEAT REACTIVE RESULTS WHEN USING THE ALINITY S HIV AG/AB COMBO ASSAY FOR THE MONTH OF (B)(6) 2023. THE FOLLOWING SID AND REAGENT LOT NUMBER AFFECTED THAT GENERATED REPEAT REACTIVE RESULTS ON THE ALINITY S SYSTEM BUT TESTED NEGATIVE ON THE CUSTOMER¿S CONFIRMATORY BIO-RAD GEENIUS HIV 1 / 2 ASSAY (ACTUAL VALUES WERE NOT PROVIDED): LOT 45152BE00: (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740253 ALINITY S HIV AG/AB COMBO REAGENT KIT HUMAN IMMUNODEFICIENCY VIRUS TYPES 1 AND 2 AG, AB (P24) AND SYNTHETIC PEPTIDES QHM ABBOTT GMBH 45152BE00 00380740117184

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY S SYSTEM, 06P16-01, AS1235| ALNTY S SYSTEM, 06P16-01, AS1235