BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 8278126 · Received January 25, 2019

    Report

    Report Number
    1628664-2019-00055
    Event Type
    Injury
    Date Received
    January 25, 2019
    Date of Event
    January 7, 2019
    Report Date
    April 22, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740005924
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 ISSUE WAS RESOLVED WHEN MAINTENANCE PROCEDURE 6018 (CLEAN CUVETTE WASHER NOZZLES) WAS PERFORMED TO CLEAR THE INADEQUATE LIQUID WASTE ASPIRATION BY THE CLOGGED CUVETTE WASHER NOZZLES. THE LOG REVIEW CONFIRMS NO ADDITIONAL DISCREPANT RESULTS WERE OBTAINED AND THE ISSUE WAS RESOLVED AFTER THE CUVETTE WASHER NOZZLES WERE CLEANED (PN 7-202584-03). 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 CREATININE RESULTS ON THE ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), 2 RESULTS WERE AMENDED: NA = 174 TO 147 MMOL/L AND CREATININE = 6.2 MG/DL TO 1.1. THIS PATIENT WAS TREATED BASED THE INITIAL RESULTS. UNKNOWN WHAT TREATMENT WAS PROVIDED. SID (B)(6), 1 RESULT WAS AMENDED: CREAT = 6.5 TO 1.5. SID (B)(6), 1 RESULT WAS AMENDED: TBIL = 1.30 MG/DL 0.9. THIS PATIENT WAS REDRAWN BECAUSE CLINICIAN DID NOT BELIEVE RESULTS. SID (B)(6), 1 RESULT WAS AMENDED: CREAT = 2.4 TO 0.9. SID (B)(6), 1 RESULT WAS AMENDED: BUN = 84 TO 67 MG/DL. THE UNKNOWN TREATMENT DUE TO FALSELY ELEVATED CREATININE RESULTS REPRESENTS A SERIOUS INJURY. NO FURTHER PATIENT DETAILS, TREATMENT DETAILS OR PATIENT OUTCOME ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70102 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740005924

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CREATININE REAGENTS| CREATININE REAGENTS| LN 03L81-32 LOT 86465UN18| LN 03L81-32 LOT 86465UN18| "LN" 03L81-32 LOT 86465UN18| CREATININE REAGENTS