BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I CMV IGG REAGENT KIT

    MDR report key: 20803105 · Received November 27, 2024

    Report

    Report Number
    3008344661-2024-00142
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 11, 2024
    Report Date
    January 22, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LFZ
    UDI-DI
    00380740129798
    PMA / PMN Number
    K220949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TICKET SEARCH BY LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY RELATED TRENDS REGARDING COMMONALITIES FOR LOT NUMBER AND COMPLAINT ISSUE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH COMPLAINT LOT AND THE COMPLAINT ISSUE. IN HOUSE TESTING WAS CONDUCTED ON LOT NUMBER 64302FZ00, AND THE TESTING DETERMINED THE SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P42-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33, WITH 510K/PMA/BLA NUMBER K220949. A1 PATIENT IDENTIFIER: SAMPLE ID IS (B)(6). 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 REACTIVE ALINITY I CMV IGG AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6), INITIAL RESULT WAS 26.868 AND REPEAT RESULTS WERE 0.033, 0.308, & 0.384 (REFERENCE: = 6 AU/ML IS REACTIVE). PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE REACTIVE ALINITY I CMV IGG AND PROVIDED THE FOLLOWING DATA: SAMPLE ID (B)(6) INITIAL RESULT WAS 26.868 AND REPEAT RESULTS WERE 0.033, 0.308, & 0.384 (REFERENCE: = 6 AU/ML IS REACTIVE) PER THE CUSTOMER THE DISCREPANT RESULTS WERE NOT REPORTED OUT TO THE PATIENT¿S MEDICAL PROVIDER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2614209 ALINITY I CMV IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ABBOTT IRELAND DIAGNOSTICS DIVISION 64302FZ00 00380740129798

    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)