BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS VITAMIN B12

    MDR report key: 21264257 · Received January 29, 2025

    Report

    Report Number
    2122870-2025-00056
    Event Type
    Injury
    Date Received
    January 29, 2025
    Date of Event
    December 27, 2024
    Report Date
    February 26, 2025
    Manufacturer
    BECKMAN COULTER, INC
    Product Code
    CDD
    UDI-DI
    15099590224301
    PMA / PMN Number
    K223289
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED. BECKMAN COULTER HAS DETERMINED THAT SOME ACCESS VITAMIN B12 REAGENT PACKS FROM LOT 439850 WERE NON-CONFORMING. A FIELD ACTION (FA-25021) WILL ADDRESS THE ISSUE. CUSTOMER'S ARE ADVISED TO STOP USE OF ACCESS VITAMIN B12 REAGENT KIT, PART NUMBER 33000, LOT NUMBER 439850. FOLLOW-UP MEDWATCH REPORT UPDATES SUMMARY: G6: FOLLOW-UP. H2: DEVICE EVALUATION. H6: - COMPONENT CODE 3050 DEVICE INGREDIENT OR REAGENT. - INVESTIGATION FINDINGS (B)(4) MANUFACTURING PROCESS PROBLEM IDENTIFIED. - INVESTIGATION CONCLUSIONS (B)(4) CAUSE TRACED TO MANUFACTURING. H11: CORRECTED DATA.

    Additional Manufacturer Narrative · 0

    A1: THE FULL PATIENT IDENTIFIER IS (B)(4). A2, A3, A4 AND A5: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. H3 AND H6: NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THE LOCAL SUPPORT ADVISED THE CUSTOMER TO STOP USING THE REAGENT LOT 439850 AND HELPED THE CUSTOMER TO MONITOR AND REPEAT PATIENT RESULTS. THE ISSUE IS CURRENTLY ESCALATED TO GLOBAL PRODUCT TECHNICAL SUPPORT (GPTS) AND TO TECHNICAL OPERATIONS TEAM SUPPORT (TOTS). AN INTERNAL INVESTIGATION WILL BE PERFORMED ON THE ACCESS VITAMIN B12 REAGENT PART NUMBER 33000, REAGENT LOT 439850. IN CONCLUSION, TO DATE, THE EXACT CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE INFORMATION SUPPLIED. TO DATE, THERE IS NO CONFIRMED MALFUNCTION OF THE REAGENT. NOTE: A SECOND MEDWATCH REPORT ALREADY ADDRESS THE SECOND PATIENT WITH CHANGE IN TREATMENT (B)(4).

    Description of Event or Problem · 0

    ON 03JAN2025 THE CUSTOMER REPORTED FALSE LOW VITAMIN B12 PATIENT RESULTS (ACCESS VITAMIN B12, PART NUMBER 33000 AND LOT NUMBER 439850) WERE GENERATED ON THE CUSTOMER'S DXI ANALYZERS (DXI 800 ACCESS IMMASSY W/SPOT B, PART NUMBER A71456 AND SERIAL NUMBERS (SN) (B)(6)). THE CUSTOMER REPORTED THAT TWO PATIENTS HAD A CHANGE IN TREATMENT BASED ON THE FALSE LOW ACCESS VITAMIN B12 RESULTS. THIS REPORT WILL ADDRESS THE PATIENT WHO STARTED ORAL VITAMIN B12 SUPPLEMENTATION BASED ON THE LOW VITAMIN B12 RESULT OBTAINED ON (B)(6) 2024. THE INITIAL VITAMIN B12 RESULT WAS 85.1 PMOL/L ON DXI SN (B)(6) ON (B)(6) 2024, REPEATED AT 119.7 PMOL/L. PATIENT RESULT WAS AMENDED. THE CUSTOMER'S VITAMIN B12 REFERENCE RANGE WAS 115-1000 PMOL/L. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS INCIDENT. SYSTEM CHECK DATA WAS NOT PROVIDED. CALIBRATIONS PASSED WITH REAGENT LOT 439850 ON BOTH INSTRUMENTS. THE FIELD APPLICATION SPECIALIST (FAS) ANALYZED QUALITY CONTROL (QC) DATA AND FOUND THAT THE 3 LEVELS OF QC RAN ON BOTH DXI INSTRUMENTS WERE ERRATIC WITH HIGH %CV AND OUTSIDE HIGH OR LOW SD VALUES. THE CUSTOMER STATED SOME HIGH VITB12 QC RESULTS WERE >1134 WITH ¿NO VALUE¿. MOST OF QUESTIONED QC RESULTS WERE OBTAINED ON VITB12 REAGENT LOT 439850. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. NOTE: A SECOND MEDWATCH REPORT ALREADY ADDRESS THE OTHER PATIENT WITH CHANGE IN TREATMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792682 ACCESS VITAMIN B12 RADIOASSAY, VITAMIN B12 CDD BECKMAN COULTER, INC 439850 15099590224301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other