BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 19645360 · Received July 1, 2024

    Report

    Report Number
    3005094123-2024-00360
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 17, 2024
    Report Date
    August 1, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P51-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21.

    Additional Manufacturer Narrative · 0

    RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. THE TICKET SEARCH DETERMINED THAT THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. THE OVERALL PERFORMANCE OF ALINITY I TOTAL SS-HCG REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE NUMBER OF STANDARD DEVIATIONS TO THE CUT-OFF AND THE MEDIAN OF THE NEGATIVE POPULATIONS IS WITHIN THE ESTABLISHED LIMITS AND WITHIN THE HISTORICAL RANGE OF THE ALINITY I TOTAL SS-HCG ASSAY. ADDITIONALLY, ACCURACY OF THE ALINITY I TOTAL SS-HCG ASSAY HAS BEEN EVALUATED WITH A RETAINED IN-HOUSE KIT OF THE SAME LOT# 61904UD02 AND MET ALL SPECIFICATIONS, CONFIRMING THAT THIS LOT IS MEETING THE ALINITY I TOTAL SS-HCG PRODUCT REQUIREMENTS. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I TOTAL SS-HCG LOT# 61904UD02.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT ON A 33-YR OLD FEMALE PATIENT (POST ABORTION) THAT WAS NOT REPORTED OUT OF THE LABORATORY. RESULTS PROVIDED: (B)(6) 2024 SID (B)(6) / < 2.3 MIU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT ON A 33-YR OLD FEMALE PATIENT (POST ABORTION) THAT WAS NOT REPORTED OUT OF THE LABORATORY. RESULTS PROVIDED: (B)(6) 2024 SID (B)(6) = 41.04 / < 2.3 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572290 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 61904UD02

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)