BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HSV-1 IGG REAGENT KIT

    MDR report key: 19426521 · Received May 30, 2024

    Report

    Report Number
    3008344661-2024-00064
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    June 1, 2023
    Report Date
    July 12, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MXJ
    UDI-DI
    00380740196431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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, AND DEVICE HISTORY RECORD REVIEW. 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. THE TICKET SEARCH BY LOT INDICATES THAT THE COMPLAINT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I HSV-1 IGG REAGENT LOT 01307L822 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 04W20-25 AND THERE IS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER SIMILAR US LN 04W20-27/37. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NON-REACTIVE ALINITY I HSV-1 IGG. THE CUSTOMER REPORTED THAT THIS HAS BEEN OCCURRING FOR AN UNDEFINED LENGTH OF TIME AND PROVIDED THE FOLLOWING EXAMPLE DATA: FOR JUNE 2023, 19 SAMPLE WERE PROCESSED AND GENERATED THE FOLLOWING RESULTS: FOR HSV I THERE WERE 18 REACTIVE SAMPLES BY IFI TESTING AND 10 REACTIVE SAMPLES FROM ALINITY PLATFORM. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NON-REACTIVE ALINITY I HSV-1 IGG. THE CUSTOMER REPORTED THAT THIS HAS BEEN OCCURRING FOR AN UNDEFINED LENGTH OF TIME AND PROVIDED THE FOLLOWING EXAMPLE DATA: FOR (B)(6) 2023, 19 SAMPLE WERE PROCESSED AND GENERATED THE FOLLOWING RESULTS: FOR HSV I THERE WERE 18 REACTIVE SAMPLES BY IFI TESTING AND 10 REACTIVE SAMPLES FROM ALINITY PLATFORM. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285542 ALINITY I HSV-1 IGG REAGENT KIT ENZYME LINKED IMMUNOSORBENT ASSAY, HERPES SIMPLEX VIRUS, HSV-1 MXJ ABBOTT IRELAND DIAGNOSTICS DIVISION 01307L822 00380740196431

    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)