BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® VITAMIN B12

    MDR report key: 2435593 · Received February 1, 2012

    Report

    Report Number
    2122870-2012-00228
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    January 5, 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. QC PERFORMED TO TROUBLESHOOT THIS EVENT FAILED. SYSTEM CHECK DATA FROM THIS TIME IS WITHIN SPECIFICATIONS. SERVICE WAS DISPATCHED ON (B)(4) 2012. ALTHOUGH ALL SYSTEM VERIFICATION TESTS RECOVERED WITHIN THE SPECIFICATIONS, A PRECISION RUN USING CONTROL MATERIALS FAILED, GIVING RESULTS OF GREATER THAN 1513 PG/ML. PATIENT SAMPLES WERE THEN RUN AND ALSO PRODUCED RESULTS GREATER THAN 1513 PG/ML. THESE REAGENT PACKS ARE BEING INVESTIGATED BY BEC CUSTOMER PRODUCT LINE SUPPORT (CPLS). INVESTIGATION RESULTS ARE PENDING AT THIS TIME, AND NO ROOT CAUSE OF THIS EVENT HAS BEEN DETERMINED TO DATE.

    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 ON THE OTHER INSTRUMENT ON (B)(6) 2011 AND (B)(6) 2012 ARE DOCUMENTED IN MDR #2122870-2012-00226 AND 2122870-2012-00229, RESPECTIVELY. THE PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING INTERMITTENTLY PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. AFTER REPLACING THE QUESTIONED REAGENT PACKS, THE CUSTOMER OBTAINED QC RESULTS WITHIN THEIR ESTABLISHED RANGES AND PATIENT RESULTS THAT BETTER MATCHED CLINICAL PRESENTATION. UPON PHYSICAL EXAMINATION, THE REAGENT PACKS PRODUCING THE QUESTIONED RESULTS LOOKED DIFFERENT WITH LIGHTER COLOR THAN THE REAGENT PACKS THAT PRODUCED ACCEPTABLE RESULTS. AFTER CHECKING THE BARCODES ON THE REAGENTS PACKS, IT APPEARED THERE WAS A PROBLEM WITH A PORTION OF REAGENT LOT 170089. THE POTENTIALLY PROBLEMATIC REAGENTS WERE SEGREGATED AND REAGENTS OF NEW LOT WERE ORDERED. 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 03/20/2006. 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