BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOTAL B-HCG REAGENT KIT

    MDR report key: 20320695 · Received September 27, 2024

    Report

    Report Number
    3005094123-2024-00500
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    September 8, 2024
    Report Date
    November 19, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    DHA
    UDI-DI
    00380740121518
    PMA / PMN Number
    K170317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETED INFORMATION FOR SECTION A1 PATIENT IDENTIFIER: SID (B)(6). 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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P51-30 HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P51-21/-31.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION 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 IN HOUSE TESTING OF A RETAINED REAGENT KIT LOT 60340UD00. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A SEARCH FOR SIMILAR COMPLAINTS DID IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 60340UD00, HOWEVER, NO RELATED TRENDS WERE IDENTIFIED REGARDING COMMONALITIES FOR COMPLAINT LOT NUMBER AND ISSUE. ADDITIONALLY, IN-HOUSE ACCURACY TESTING WAS COMPLETED WITH A RETAINED KIT OF LOT 60340UD00. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT 60340UD00 AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I TOTAL SS-HCG REAGENT LOT 60340UD00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT FOR ONE SAMPLE THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2024 SID (B)(6) INITIAL RESULT = 42.1 MIU/ML (POSITIVE), REPEAT WAS <2.30 MIU/ML (NEGATIVE), REPEAT ON ANOTHER ALINITY WAS <2.30 MIU/ML (NEGATIVE) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE ALINITY I TOTAL B-HCG RESULT FOR ONE SAMPLE THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2024 SID (B)(6) INITIAL RESULT = 42.1 MIU/ML (POSITIVE), REPEAT WAS <2.30 MIU/ML (NEGATIVE), REPEAT ON ANOTHER ALINITY WAS <2.30 MIU/ML (NEGATIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684942 ALINITY I TOTAL B-HCG REAGENT KIT SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT IRELAND DIAGNOSTICS DIVISION 60340UD00 00380740121518

    Patients

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