BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1248543 · Received December 3, 2008

    Report

    Report Number
    1628664-2008-00249
    Event Type
    Malfunction
    Date Received
    December 3, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE COMPLAINT TEXT INDICATES THE PATIENT SAMPLE PRODUCED AN UNFLAGGED CALCIUM RESULT OF 0.87 MMOL/L (3.48 MG/DL) ON (B)(6) 2008. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO REQUESTED A RETEST OF THE SAMPLE. THE SAMPLE WAS RESPUN AND GENERATED A RESULT OF 2.62 MMOL/L (10.48 MG/DL). THE INITIAL EXTENSIVE ANALYTICAL PANEL OF RESULTS WAS REPRODUCED WITH VALUES CONSISTENT WITH THE INITIAL RESULTS. THE INSTRUMENT QUALITY CONTROL AND OTHER PARAMETERS REMAINED STABLE AND IN RANGE DURING THE DURATION OF THE TESTING. THE INSTRUMENT LOW LINEARITY PARAMETER IS SET TO ZERO ON THE INSTRUMENT. PREVENTATIVE AND QUARTERLY MAINTENANCE WAS PERFORMED SEVEN DAYS BEFORE WHEN THE ABBOTT FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE. THE SPECIMEN WAS ADEQUATELY FILLED IN A BECTON DICKINSON PST VACUTAINER GEL HEPARIN TUBE (PRODUCT NUMBER (B)(4)). THERE WAS APPROXIMATELY 1ML OF CLEAR SUPERNATANT REMAINING ON THE GEL INTERFACE. THE FIRST 3 DIGITS OF THE LOT NUMBER OF THE COLLECTION TUBE WERE 819; THE REMAINDER OF THE NUMBERS WERE COVERED BY THE SAMPLE IDENTIFICATION LABEL ON THE TUBE (THE PRODUCT NUMBER AND PARTIAL LOT NUMBER OF THE COLLECTION TUBE DID NOT MATCH ANY OF THE NUMBERS PROVIDED BY BECTON DICKINSON IN A CUSTOMER LETTER CONCERNING CONTAMINATED HEPARIN IN THESE TUBES). BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE ISSUE WAS NOT IDENTIFIED, NOR WAS ANY DEFICIENCY IDENTIFIED IN THIS COMPLAINT FOR ANY ABBOTT PRODUCT. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED. THE CUSTOMER'S ISSUE IS ADDRESSED IN THE ARCHITECT SYSTEM OPERATIONS MANUAL ((B)(4) JUNE, 2007): SECTION 7, OPERATIONAL PRECAUTIONS AND LIMITATIONS: LIMITATIONS OF RESULT INTERPRETATION AND IN SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS, OBSERVED PROBLEMS, ERRATIC RESULTS, POOR PRECISION (C SYSTEM). ALSO, THE CLINICAL CHEMISTRY CALCIUM REAGENT PACKAGE INSERT (B)(4), DESCRIBES SUITABLE SPECIMENS, RESULTS, AND LIMITATIONS OF THE PROCEDURE FOR THIS ASSAY. A MALFUNCTION OF THE SYSTEM WAS NOT IDENTIFIED AS THE INSTRUMENT SYSTEM IS PERFORMING AS INTENDED. THE INVESTIGATION DEMONSTRATED THAT ARCHITECT C8000 SYSTEM IS PERFORMING WITHIN ITS INTENDED USE, LABEL CLAIMS AND SPECIFICATIONS. NO DEFICIENCY RELATED TO THE PERFORMANCE OF THE DEVICE WAS IDENTIFIED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: COLLECTION TUBE BECTON DICKINSON PST VACUTAINER GEL HEPARIN TUBE PRODUCT NUMBER: 8083883 LOT NUMBER OBSCURED BY ID LABEL. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A PHYSICIAN QUESTIONED ONE PATIENT'S CALCIUM ASSAY RESULT OF 0.87 MMOL/L (3.48 MG/DL) TESTED ON THE ARCHITECT C8000 ANALYZER. THE CUSTOMER RECENTRIFUGED AND RETESTED THE SAMPLE AND GENERATED A RESULT OF 2.62 MMOL/L (10.48 MG/DL). CONTROLS HAVE REMAINED WITHIN SPECIFICATIONS. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR CC CALCIUM LN: 7D61-20 LOT#: UNK| CC CALCIUM LN: 7D61-20 LOT#: UNK