BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 2402985 · Received January 7, 2012

    Report

    Report Number
    2122870-2012-00029
    Event Type
    Malfunction
    Date Received
    January 7, 2012
    Date of Event
    December 7, 2011
    Report Date
    December 8, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAS NOT BEEN SUPPLIED. PER THE CUSTOMER SUPPLIED QC DATA, ALL THREE LEVELS OF BHCG QC WERE OUT OF RANGE LOW >2-3SD ON THE EVENING OF (B)(6) 2011. BEC INVESTIGATION SHOWED THAT ALL THREE LEVELS OF BHCG QC WERE WITHIN THE ESTABLISHED RANGES EARLIER THAT SAME DAY. PER THE CUSTOMER SUPPLIED DOCUMENTATION, A ROUTINE SYSTEM CHECK WAS PERFORMED EARLIER ON (B)(6) 2011 AND THE RESULTS PASSED WITHIN THE INSTRUMENT SPECIFICATIONS. THE CUSTOMER RE-CALIBRATED THE ASSAY ON (B)(6) 2011 AT 11:50 USING CALIBRATOR LOT # 010662. THE S0 RLUS (RELATIVE LIGHT UNITS) OBTAINED WERE (B)(4). A PREVIOUS CALIBRATION PERFORMED BY THE CUSTOMER ON (B)(6) 2011 WITH THE SAME CALIBRATOR LOT # 010662 HAD PRODUCED S0 RLUS OF (B)(4), AND BEC RELEASED DATA INDICATES EXPECTED S0 RLUS OF (B)(4) FOR LOT # 010662. FURTHER INVESTIGATION BY BEC DETERMINED THAT CALIBRATOR LOT # 010662 HAS AN EXPIRATION DATE OF 09/30/2011. THEREFORE, THE CUSTOMER WAS USING EXPIRED CALIBRATOR MATERIAL. INTERNAL TESTING DEMONSTRATED THAT THE ACCESS 2 DOES NOT NOTIFY THE USER THAT THEY ARE ABOUT TO USE AN EXPIRED CALIBRATOR UNLESS THAT CALIBRATOR HAS NEVER BEEN LOADED ONTO THE SYSTEM BEFORE, REQUIRING IT TO BE SCANNED OR MANUALLY ENTERED BY THE CUSTOMER. THEREFORE, IF THE CALIBRATOR LOT HAS BEEN USED IN THE PAST AND IS STORED IN THE SYSTEM, THE ACCESS 2 ALLOWS USE OF THE CALIBRATOR EVEN PAST ITS EXPIRATION DATE. PER THE CUSTOMER SUPPLIED EVENT LOG, THERE WERE NO ERRORS POSTED IN CONJUNCTION WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BCI) THAT IND (INDETERMINATE) FLAGGED TOTAL BETA HCG (TBHCG) RESULTS WERE GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PATIENTS AND QC. ACCESS TOTAL B-HCG CALIBRATORS (ACCESS TOTAL BETA HCG CALIBRATORS: CATALOGUE NUMBER 33505, PRODUCT CODE JHI, RADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN, 510(K) NUMBER K023480.) LOT 010662 WAS USED FOR CALIBRATION. SUBSEQUENT TESTING AFTER RECALIBRATION WITH A NEW CALIBRATOR SET, LOT 017956, PRODUCED REPORTABLE RESULTS FOR BOTH PATIENTS AND THE QC RESULTS WERE WITHIN THE SPECIFICATIONS. THE REPEAT TEST RESULTS WERE NOT PROVIDED. IT WAS FOUND THAT THE CALIBRATOR LOT 010662 WAS EXPIRED ON 09/30/2011. THE CUSTOMER DOES NOT KNOW WHEN THE ERROR BEGAN AND THEREFORE, IT IS UNKNOWN IF THERE WAS ANY CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER DHA BECKMAN COULTER, INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR