BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS VITAMIN B12 REAGENT

    MDR report key: 10683918 · Received October 15, 2020

    Report

    Report Number
    2122870-2020-00088
    Event Type
    Injury
    Date Received
    October 15, 2020
    Date of Event
    August 24, 2020
    Report Date
    October 15, 2020
    Manufacturer
    BECKMAN COULTER
    Product Code
    CDD
    UDI-DI
    15099590224301
    PMA / PMN Number
    K140496
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE ACCESS VITAMIN B12 REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECKS AND CALIBRATIONS WERE NOT PROVIDED FOR REVIEW. ALTHOUGH THE CUSTOMER'S LEVEL 1 AND LEVEL 3 QUALITY CONTROL WERE NOTED TO SHIFT LOW WITH THE SPECIFIC LOT OF REAGENT USED, THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION OCCURRED. CUSTOMER'S LEVEL 2 QUALITY CONTROL WAS PASSING WITHIN SPECIFICATIONS. (B)(4). IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUS LOW VITAMIN B12 (ACCESS VITAMIN B12, PART NUMBER (B)(4) AND LOT NUMBER 921766) RESULTS WERE GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY ANALYZERS (DXI) (PART NUMBER (B)(4) AND SERIAL NUMBERS (B)(4) AND (B)(4). THE CUSTOMER REPORTED ADDITIONAL ERRONEOUS LOW VITAMIN B12 RESULTS WERE ALSO GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY ANALYZERS AT AN ALTERNATE SITE (DXI PART NUMBERS AND SERIAL NUMBERS NOT PROVIDED). THE INITIAL RESULTS WERE RELEASED FROM THE LABORATORY. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. ON (B)(6) 2020 THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF PATIENTS RECEIVED VITAMIN B12 INJECTIONS (DOSES NOT PROVIDED). THERE WAS NO FURTHER INFORMATION REGARDING CHANGE TO PATIENT TREATMENT OR MANAGEMENT OR PATIENT OUTCOME PROVIDED. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECKS AND CALIBRATIONS WERE NOT PROVIDED FOR REVIEW. THERE WAS NO REPORT OF HARDWARE ERRORS OR OTHER ISSUES WITH THE DXI INSTRUMENTS. NO OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. QUALITY CONTROL INFORMATION PROVIDED DEMONSTRATED A SHIFT LOWER IN THE CUSTOMER' QUALITY CONTROL LEVELS 1 AND 3. LEVEL 2 QUALITY CONTROL REMAINED STABLE. CUSTOMER DID NOT REPORT SAMPLE INTEGRITY ISSUES. SAMPLE COLLECTION INFORMATION SUCH AS SAMPLE TYPE AND VOLUME DRAWN, CENTRIFUGATION TIME AND SPEED, SAMPLE HANDLING OR PROCESSING WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149985 ACCESS VITAMIN B12 REAGENT RADIOASSAY, VITAMIN B12 CDD BECKMAN COULTER 33000 921766 15099590224301

    Patients

    Seq Age Sex Outcome Treatment
    1 Other