BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® VITAMIN B12

    MDR report key: 2435606 · Received February 1, 2012

    Report

    Report Number
    2122870-2012-00229
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 6, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CDD
    PMA / PMN Number
    K955436
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUPPLIED DATA SHOWS THAT THE CALIBRATIONS WERE PASSING, BUT RLU (RELATIVE LIGHT UNITS) VALUES WERE EXTREMELY SUPPRESSED COMPARED TO RELEASE DATA. NO FURTHER SUPPORTING DOCUMENTS FOR THIS EVENT WERE SUPPLIED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BEC) THAT ERRONEOUSLY ELEVATED VITAMIN B12 RESULTS WERE INTERMITTENTLY GENERATED BY UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR QC AND MULTIPLE PATIENTS. ONE LOT OF ACCESS VITAMIN B12 REAGENT WAS USED ON TWO DIFFERENT UNICEL DXI 800 INSTRUMENTS. THIS REPORT DOCUMENTS THE EVENT ON ONE OF THE TWO INSTRUMENTS, SERIAL NUMBER (B)(4) ON (B)(6) 2012. THE RELATED EVENTS ARE DOCUMENTED IN THE BELOW LISTED MDRS: 2122870-2012-00226, 2122870-2012-00228. THE PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. AFTER RECALIBRATION, THE CUSTOMER OBTAINED QC RESULTS WITHIN THEIR ESTABLISHED RANGES AND PATIENT RESULTS THAT BETTER MATCHED CLINICAL PRESENTATION. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM: CATALOGUE NUMBER 973100, SERIAL NUMBER (B)(4), DATE OF MANUFACTURE 08/12/2011. PRODUCT CODE JJE, ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE 510(K) K023764.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® VITAMIN B12 RADIOASSAY, VITAMIN B12 CDD BECKMAN COULTER, INC. NA 170089

    Patients

    Seq Age Sex Outcome Treatment
    1