BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 3203115 · Received July 2, 2013

    Report

    Report Number
    1628664-2013-00170
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K981578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM THE ASSAY (CLINICAL CHEMISTRY CALCIUM LN 03L79-21 LOT 84871UN12) TO THE INSTRUMENT (ARCHITECT C8000 ANALYZER LN 01G06-11 SN (B)(4)) ON JULY 2, 2013 (AS UPDATED). BOTH THE INSTRUMENT AND ASSAY ARE MANUFACTURED AT THE SAME SITE ((B)(4)). THE CUSTOMER PERFORMED TROUBLESHOOTING WITH NO RESOLUTION. ABBOTT FIELD SERVICE VISITED THE CUSTOMER AND REPLACED THE MIXER TO RESOLVE THE ISSUE. ON JULY 15, 2013 THE PRODUCT INVESTIGATION OF THE CUSTOMER ISSUE WAS COMPLETE. THE INVESTIGATION INCLUDED A REVIEW OF HISTORICAL DATA, DEVICE HISTORY RECORD REVIEW, A REVIEW OF LABELING AND SERVICE TO THE INSTRUMENT. REVIEW OF THE DATA DID NOT IDENTIFY ANY PRODUCT ISSUE OR ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. REPLACEMENT OF THE MIXER ON THE ARCHITECT ANALYZER RESOLVED THE ISSUE. BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS INVESTIGATION NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED DISCREPANT CALCIUM RESULTS FOR ONE PATIENT WHILE USING THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED (IN MMOL/L): INITIAL 1.37, REPEAT 2.43. THE CUSTOMER USES A NORMAL RANGE FOR CALCIUM OF 2.10 TO 2.55 MMOL/L. ABBOTT SERVICE WAS DISPATCHED AND THE SMARTWASHES WERE INCREASED, AFTER THE SAMPLE, R1 AND R2 NEEDLES WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301327 ARCHITECT C8000 SYSTEM JJE ABBOTT MANUFACTURING INC 84871UN12

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 03L79-21 LOT 84871UN12| LN 01G06-11 SN (B)(4)| ARCHITECT C8000 ANALYZER| ARCHITECT CLINICAL CHEMISTRY CALCIUM