BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I B12 REAGENT KIT

    MDR report key: 23116302 · Received September 22, 2025

    Report

    Report Number
    3005094123-2025-00467
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    September 5, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    CDD
    UDI-DI
    00380740131418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6 MEDICAL DEVICE PROBLEM CODE WAS UPDATED FROM A090809 TO A0908. 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 REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I B12 REAGENT DID NOT IDENTIFY ANY TREND REGARDING COMMONALITIES FOR LOT NUMBER AND ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES ASSOCIATED WITH LOT NUMBER 72282UD00 AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ALINITY I B12 REAGENTS IN THE FIELD WAS REVIEWED USING DATA FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN RESULT FOR THE LOT WAS ANALYZED AND FOUND TO BE COMPARABLE TO ALL OTHER LOTS IN THE FIELD AND CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. A REVIEW OF THE LABELLING ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I B12 ASSAY, LOT 72282UD00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    A1 PATIENT IDENTIFIER: THE COMPLETE SAMPLE ID B)(6). E1 PHONE NUMBER: COMPLETE PHONE NUMBER IS (B)(6). 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 7P67-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P67-21 / 31, WITH NUMBER 510K K121314.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED IMPRECISE ALINITY I B12 RESULTS FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) INITIAL RESULT (B)(6) 2025 174 PG/ML. REPEATED RESULTS: (B)(6) 2025, 1102 PG/ML (B)(6), (B)(6) 2025, 1014 PG/ML (B)(6), (B)(6) 2025 ,510 PG/ML (B)(6) , (B)(6) 2025, 486 / 483 / 474 PG/ML (B)(6), NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED IMPRECISE ALINITY I B12 RESULTS FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) INITIAL RESULT (B)(6) 2025 174 PG/ML REPEATED RESULTS: (B)(6) 2025 1102 PG/ML (B)(6). (B)(6) 2025 1014 PG/ML (B)(6). (B)(6) 2025 510 PG/ML (B)(6). (B)(6) 2025 486 / 483 / 474 PG/ML (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542534 ALINITY I B12 REAGENT KIT RADIOASSAY, VITAMIN B12 CDD ABBOTT IRELAND DIAGNOSTICS DIVISION 72282UD00 00380740131418

    Patients

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