BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS VITAMIN B12

    MDR report key: 4376635 · Received January 1, 2015

    Report

    Report Number
    2122870-2015-00001
    Event Type
    Malfunction
    Date Received
    January 1, 2015
    Date of Event
    December 2, 2014
    Report Date
    December 2, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    CDD
    PMA / PMN Number
    K140496
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE THE PATIENT'S WEIGHT. THERE IS NO INDICATION THAT THE ACCESS VITAMIN B12 REAGENT USED BY THE CUSTOMER WAS RETURNED FOR EVALUATION. BECKMAN COULTER ANALYSIS OF THE PATIENT SAMPLE INDICATED EVIDENCE OF ALKALINE PHOSPHATASE (ALP) INTERFERENCE, AS VITAMIN B12 WAS REDUCED BY 74% WITH THE ADDITION OF ALP BLOCKER. THE INSTRUCTIONS FOR USE FOR ACCESS VITAMIN B12 DOES NOT INCLUDE A LIMITATION FOR ALP INTERFERENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING AN ERRONEOUS VITAMIN B12 RESULT FOR ONE PATIENT SAMPLE ON THE LABORATORY'S UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER (B)(4)). THE INITIAL RESULT OBTAINED WAS >1500 PG/ML, WHICH WAS REPORTED OUT OF THE LABORATORY. THE PATIENT WAS EXPECTED TO BE WITHIN THE NORMAL REFERENCE RANGE FOR VITAMIN B12. THE SAMPLE WAS DILUTED 1:5 AND RE-ANALYZED ON THE SAME INSTRUMENT, WHICH YIELDED 453 PG/ML, WHICH WAS IN THE NORMAL REFERENCE RANGE. THERE IS NO REPORT OF PATIENT INJURY OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE SAMPLE WAS CENTRIFUGED AT 3000 RPM FOR 8 MINUTES. SYSTEM CHECK PASSED ON (B)(4) 2014. THE CUSTOMER SENT THE PATIENT SAMPLE TO BECKMAN COULTER FOR SAMPLE INTERFERENCE TESTING. REFERENCE RANGE FOR ACCESS VITAMIN B12: 180 - 914 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187 ACCESS VITAMIN B12 RADIOASSAY, VITAMIN B12 CDD BECKMAN COULTER NA 430162

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR