BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY S HIV AG/AB COMBO REAGENT KIT

    MDR report key: 12086104 · Received June 29, 2021

    Report

    Report Number
    3002809144-2021-00397
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    May 25, 2021
    Report Date
    September 13, 2021
    Manufacturer
    ABBOTT GMBH
    Product Code
    QHM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ALINITY S HIV AG/AB COMBO REAGENT LOT 27255BE00 IDENTIFIED NORMAL COMPLAINT ACTIVITY. RETURN SAMPLE ANALYSIS: TESTING WITH A RETAINED KIT OF ARCHITECT HIV AG/AB COMBO REAGENT LOT 27255BE00 CONFIRMED THE REACTIVE RESULT OBSERVED BY THE CUSTOMER. THE PRESENCE OF HETEROPHILIC ANTIBODIES WAS INVESTIGATED BY USING SCANTIBODIES HBT TREATMENT. OBTAINED RESULTS SUGGEST THAT HETEROPHILIC ANTIBODIES ARE PRESENT IN THE SAMPLE AND CAUSED OR CONTRIBUTED TO THE FALSE REACTIVE RESULTS. FIELD DATA REVIEW SHOWED THAT THE INITIAL AND REPEAT REACTIVE RATE OBSERVED FOR THE COMPLAINT LOT IN BLOOD BANKS MEETS THE SPECIFICITY PERFORMANCE CLAIM OF THE PACKAGE INSERT. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. THE PERFORMANCE OF THE LIKELY CAUSE LOT WAS INVESTIGATED BY COMPLETING A REVIEW FOR NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES AND DEVIATIONS RELATED TO THE LIKELY CAUSE LOT. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED WITH ALINITY S HIV AG/AB COMBO REAGENT LOT 27255BE00.

    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 NUMBER 06P01-55 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06P01-60. PATIENT IDENTIFIER COMPLETE SID: (B)(6) .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A (B)(6) REACTIVE ALINITY S HIV AG/AB COMBO RESULT ON AN (B)(6) YR OLD PATIENT. RESULTS PROVIDED: (B)(6) 2021 SID (B)(6) , REPEATED ON (B)(6) 2021 = (B)(6) , ARCHITECT ON (B)(6) 2021 = (B)(6) , NAT (B)(6) ROCHE 8800, ROCHE COBAS E801 HIV DUO IS (B)(6) , BIORAD GENIUS IS (B)(6) ; (B)(6) 2021 SID (B)(6) = (B)(6) , ARCHITECT = (B)(6) , NAT (B)(6) ROCHE 8800, ROCHE COBAS E801 (B)(6) DUO IS (B)(6) . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983904 ALINITY S HIV AG/AB COMBO REAGENT KIT HUMAN IMMUNODEFICIENCY VIRUS TYPES 1 AND 2 AG, AB (P24) AND SYNTHETIC PEPTIDES QHM ABBOTT GMBH 27255BE00

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR ALNTY S SYSTEM, 06P16-01, AS1078, (B)(4)| ALNTY S SYSTEM, 06P16-01, AS1078, (B)(4)