BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 ANALYZER

    MDR report key: 7879741 · Received September 16, 2018

    Report

    Report Number
    1628664-2018-01886
    Event Type
    Malfunction
    Date Received
    September 16, 2018
    Date of Event
    August 27, 2018
    Report Date
    October 23, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K981791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2018, THE LIKELY CAUSE CHANGED FROM LN 03P68-21 LOT UNKNOWN TO THE ANALYZER ARCHITECT C8000 LN 01G06-01 SN (B)(4), BOTH MANUFACTURED AT THE SAME LOCATION. BRAND NAME FROM CLINICAL CHEMISTRY MAGNESIUM TO ARCHITECT C8000 ANALYZER COMMON DEVICE NAME FROM MAGNESIUM TO AUTOMATED IMMUNOASSAY ANALYZER PRODUCT CODE FROM JGJ TO JJE CATALOG NUMBER UPDATED TO 01G06-01 AND SN (B)(4). CONCOMITANT FROM: ARCHITECT C8000 ANALYZER LN 01L86-01 SN (B)(4) TO ARCHITECT MAGNESIUM REAGENTS LN 03P68-21 LOT UNKNOWN ON OCT 5, 2018, THE EVALUATION WAS COMPLETED. FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE CUSTOMER PREVIOUSLY REPLACED THE SAMPLE PROBE AND PERFORMED A SAMPLE PIPETTOR CALIBRATION DURING TROUBLESHOOTING. THE FIELD SERVICE ENGINEER (FSE) OBSERVED THAT THE SAMPLE PIPETTOR WAS OUT OF ALIGNMENT. AFTER SUCCESSFULLY RECALIBRATING THE PIPETTOR, THE FSE CHECKED THE FLUIDICS, CALIBRATION OF THE R1 AND R2 PIPETTORS, AND THE INSTRUMENT IS IN WORKING ORDER. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED MAGNESIUM RESULTS ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING RESULTS WERE PROVIDED (MMOL/L): SID (B)(6) INITIAL 2.79 REPEATS 0.67, 0.64. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720631 ARCHITECT C8000 ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MANUFACTURING INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C8000 ANALYZER| ARCHITECT MAGNESIUM REAGENTS| LN 01L86-01 SN (B)(4)| LN 03P68-21 LOT UNKNOWN