BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG REAGENT KIT

    MDR report key: 20903313 · Received December 11, 2024

    Report

    Report Number
    3002809144-2024-00350
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    November 22, 2024
    Report Date
    January 20, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740131265
    PMA / PMN Number
    K210596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 - PATIENT IDENTIFIER: SIDS = (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P45-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P45-40/ 45, WITH 510K/PMA/BLA NUMBER K210596. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, A SEARCH FOR SIMILAR COMPLAINTS, A TICKET TRENDING REVIEW, A DEVICE HISTORY RECORD REVIEW, A FIELD DATA REVIEW, AND A LABELING REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORTED THE COMPLAINT ISSUE WITHOUT INDICATION OF ANY ADDITIONAL ISSUE. A TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. A REVIEW OF THE COMPLAINT TRENDING REPORT DID NOT IDENTIFY ANY TRENDS FOR THE ISSUE FOR THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH LOT NUMBER 66439BE00 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I TOXO IGG REAGENT LOT 66439BE00 WAS REVIEWED USING FIELD DATA FROM CUSTOMERS WORLDWIDE. THE MEDIAN VALUE FOR THE COMPLAINT LOT WAS WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. A REVIEW OF THE FIELD DATA SUGGESTS THAT THE PERFORMANCE IS ACCEPTABLE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I TOXO IGG REAGENT, LOT NUMBER 66439BE00.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOXO IGG RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR TWO PATIENTS WHICH DID NOT MATCH THEIR PREVIOUS RESULTS. THE SAMPLES WERE REPEATED AND NONREACTIVE RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: < 1.6 IU/ML IS NONREACTIVE; 1.6 TO < 3.0 IU/ML IS GRAYZONE; >/= 3.0 IU/ML IS REACTIVE. (B)(6) 2024 SID (B)(6): INITIAL RESULT = 14.7 IU/ML; REPEATED TWICE = BOTH NONREACTIVE. PREVIOUS RESULT = NEGATIVE. (B)(6) 2024 SID (B)(6): INITIAL RESULT = 15.0 IU/ML; REPEATED TWICE = BOTH NONREACTIVE. PREVIOUS RESULT = NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOXO IGG RESULTS GENERATED ON THE ALINITY I PROCESSING MODULE FOR TWO PATIENTS WHICH DID NOT MATCH THEIR PREVIOUS RESULTS. THE SAMPLES WERE REPEATED AND NONREACTIVE RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: < 1.6 IU/ML IS NONREACTIVE; 1.6 TO < 3.0 IU/ML IS GRAYZONE; >/= 3.0 IU/ML IS REACTIVE (B)(6) 2024 SID (B)(6), INITIAL RESULT = 14.7 IU/ML; REPEATED TWICE = BOTH NONREACTIVE, PREVIOUS RESULT = NEGATIVE. (B)(6) 2024 SID (B)(6), INITIAL RESULT = 15.0 IU/ML; REPEATED TWICE = BOTH NONREACTIVE, PREVIOUS RESULT = NEGATIVE, THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2569326 ALINITY I TOXO IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 66439BE00 00380740131265

    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)