BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® VITAMIN B12 ASSAY

    MDR report key: 3122353 · Received May 21, 2013

    Report

    Report Number
    8020879-2013-00006
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    CDD
    PMA / PMN Number
    K955436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THE REAGENT PACK DEVICE WAS RETURNED FOR EVALUATION. THE CUSTOMER INDICATED SYSTEM CHECK AND QUALITY CONTROL (QC) WERE WITHIN SPECIFICATION AT THE TIME OF THE EVENT. A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN. THIS MEDWATCH REPORT IS RELATED TO MDR 2122870-2013-00477.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED NON-REPRODUCIBLE VITAMIN B12 RESULTS, FOR SEVERAL PATIENTS, INVOLVING THE ACCESS VITAMIN B12 REAGENT USED IN CONJUNCTION WITH THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. ONE PATIENT SAMPLE PRODUCED VITAMIN B12 RESULTS OF 137, 224, AND 140 PG/ML (REFERENCE RANGE 180-914 PG/ML). THE DISCREPANT VITAMIN B12 RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THIS IS REPORT ONE OF TWO REFERENCING THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223963 ACCESS® VITAMIN B12 ASSAY RADIOASSAY, VITAMIN B12 CDD BECKMAN COULTER NA 270187

    Patients

    Seq Age Sex Outcome Treatment
    1