BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I B12 REAGENT KIT

    MDR report key: 21246671 · Received January 27, 2025

    Report

    Report Number
    3005094123-2025-00037
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    January 9, 2025
    Report Date
    March 17, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CDD
    UDI-DI
    00380740131418
    PMA / PMN Number
    K121314
    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 FIELD DATA 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. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINTS FOR LIST NUMBER 07P67, HOWEVER, AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 66522UD00 WAS NOT IDENTIFIED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. THE OVERALL PERFORMANCE OF THE ALINITY I B12 REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES OBTAINED WITH THE COMPLAINT LOT 66522UD00 IS WITHIN ESTABLISHED LIMITS AND THUS COMPARABLE TO THE HISTORICAL LOT PERFORMANCE, WHICH CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I B12 REAGENT LOT 66522UD00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P67-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P67-21 / 31 WITH 510K/PMA/BLA NUMBER K121314. 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 FALSELY ELEVATED ALINITY I B12 AND PROVIDED THE FOLLOWING DATA: THE RESULT WAS 1,466.9 PMOL/L. ANOTHER SPECIMEN TUBE WAS TESTED, AND THE RESULT WAS 213.4 PMOL/L. THE INITIAL SAMPLE WAS REPEATED WHICH GENERATED A RESULT OF 192.7 PMOL/L. THE SECOND SAMPLE WAS REPEATED WHICH GENERATED A RESULT OF 195.0 PMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY I B12 AND PROVIDED THE FOLLOWING DATA: THE RESULT WAS 1,466.9 PMOL/L. ANOTHER SPECIMEN TUBE WAS TESTED, AND THE RESULT WAS 213.4 PMOL/L. THE INITIAL SAMPLE WAS REPEATED WHICH GENERATED A RESULT OF 192.7 PMOL/L. THE SECOND SAMPLE WAS REPEATED WHICH GENERATED A RESULT OF 195.0 PMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759115 ALINITY I B12 REAGENT KIT RADIOASSAY, VITAMIN B12 CDD ABBOTT IRELAND DIAGNOSTICS DIVISION 66522UD00 00380740131418

    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)