BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® VITAMIN B12

    MDR report key: 2433755 · Received January 31, 2012

    Report

    Report Number
    2122870-2012-00226
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    December 28, 2011
    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

    MDR #2122870-2012-00228 HAS BEEN SUBMITTED TO DOCUMENT THE VITAMIN B12 RESULTS GENERATED BY THE OTHER INSTRUMENT (DXI 800 SERIAL NUMBER: (B)(4)) IN THE CUSTOMER'S LAB. MDR #2122870-2012-00229 DOCUMENTS THE RESULTS GENERATED BY THE INSTRUMENT IN THIS REPORT (DXI 800 SERIAL NUMBER: (B)(4)) ON (B)(6) 2012.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) COMPLAINING OF INTERMITTENT PROBLEMS WITH VITAMIN B12 ON 2 DIFFERENT INSTRUMENTS IN THEIR LABORATORY WITH REAGENT LOT NUMBER 170089. THIS REPORT DOCUMENTS THE RESULTS GENERATED BY UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER: (B)(4). SEPARATE REPORTS HAVE BEEN SUBMITTED TO DOCUMENT THE RESULTS GENERATED BY THE OTHER INSTRUMENT INVOLVED WITH ERRONEOUS VITAMIN B12 RESULTS IN THIS CUSTOMER'S LAB AS WELL AS FOR THE RESULTS GENERATED BY DXI 800 SERIAL NUMBER (B)(4) ON A DIFFERENT DATE. INITIALLY, IT WAS ASSUMED THAT IT WAS AN INSTRUMENT ERROR AS THE CUSTOMER HAS 3 INSTRUMENTS AND SERIAL NUMBER (B)(4) WAS THE ONLY ONE SHOWING THE ERROR. THEREFORE, THEY STOPPED RUNNING THE INSTRUMENT UNTIL BEC FIELD SERVICE ENGINEER (FSE) WENT ON-SITE. WHEN THE FSE WAS ON-SITE, THE SYSTEM CHECK AND PIPETTOR VERIFICATION PASSED. WHEN QC WAS RUN ACROSS THE PIPETTORS, IT FAILED WITH RESULTS >1513NG/ML. PATIENT SAMPLES WERE RUN AND THE RESULTS WERE NEARLY ALWAYS >1513NG/ML. HOWEVER, INTERMITTENTLY A RESULT WAS GENERATED THAT WHEN RERUN ON ANOTHER INSTRUMENT WOULD BE 1/2 THE INITIAL RESULT. WHEN THE REAGENT PACKS WERE CHECKED IT WAS NOTICED THAT IN SOME PACKS COMPARTMENT WAS A MUCH LIGHTER COLOR THAN OTHER PACKS. IT LOOKED LIKE THERE WERE NOT ENOUGH MAGNETIC PARTICLES PRESENT IN SOME KITS. RUNNING A KIT WITH A LIGHTER COLOR YIELDED A RESULT OF >1513NG/ML, WHILE RUNNING A KIT WHICH LOOKED NORMAL GAVE A PROPER RESULT. AFTER LOOKING AT THE BARCODE NUMBERS, IT APPEARED THAT THERE WAS A PROBLEM WITH REAGENT LOT NUMBER 170089. THE CUSTOMER IS RERUNNING UNUSUAL RESULTS ON A DIFFERENT INSTRUMENT FOR VERIFICATION. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. A NEW LOT NUMBER OF REAGENT WAS ORDERED FOR THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1