BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1192608 · Received October 10, 2008

    Report

    Report Number
    1628664-2008-00233
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    September 14, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON DISCUSSION BETWEEN DR. (B)(6) (ABBOTT DIAGNOSTICS DIVISION MEDICAL DIRECTOR) AND (B)(6) (FOOD & DRUG ADMINISTRATION, SCIENTIFIC REVIEWER) ON (B)(6), 2008, THIS FOLLOW-UP MEDWATCH 3500A REPORT IS BEING SUBMITTED TO INDICATE ADVERSE EVENT, DEATH PER (B)(6) RECOMMENDATION.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION WAS PERFORMED IN RESPONSE TO THE CUSTOMER'S COMPLAINT OF A DISCREPANT CREATININE PATIENT RESULT GENERATED BY ARCHITECT C8000 (B)(4) ON (B)(4) 2008. THE INVESTIGATION OF THE ISSUE CONSISTED OF A REVIEW OF CUSTOMER COMPLAINTS, CURRENT ARCHITECT C8000 LABELING, AND THE INFORMATION PROVIDED INCLUDING THE COMPLAINT TEXT. THE REPLACEMENT OF POPPET VALVES ON THE C8000 APPEARS TO HAVE RESOLVED THE CUSTOMER'S DISCREPANT RESULT ISSUE. NO ADDITIONAL DISCREPANT RESULT OCCURRENCES BY ARCHITECT C8000 (B)(4) HAVE BEEN REPORTED SINCE THE POPPET VALVES WERE REPLACED. RESULTS OF THE INVESTIGATION DETERMINED THAT THERE WAS NO PRODUCT DEFICIENCY. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT AN ARCHITECT C8000 CREATININE RESULT OF 76 UMOL/L WAS REPORTED ON A FEMALE PATIENT IN 2008. A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS TESTED THE PREVIOUS NIGHT AT A DIFFERENT LABORATORY USING THE BECKMAN CREATININE METHOD AND THE RESULT WAS 400 UMOL/L. THE PHYSICIAN REQUESTED THAT THE ARCHITECT C8000 RESULT BE VERIFIED. THE SAMPLE RETESTED AT 370 UMOL/L. THE PATIENT HAD BEEN GIVEN RADIOGRAPHIC CONTRAST MEDIA. THE CUSTOMER STATED THAT THE PATIENT EXPIRED AND THAT THE PATHOLOGIST COULD NOT CONFIRM THE CAUSE OF DEATH, BUT STATED THAT THE PATIENT'S LABORATORY RESULTS INDICATED THAT THE PATIENT HAD A MYOCARDIAL INFARCTION. THERE IS NO INDICATION THAT THE ARCHITECT C8000 CREATININE RESULTS CAUSED OR CONTRIBUTED TO THE PATIENT DEATH.

    Description of Event or Problem · 1

    THE PATHOLOGIST STATED THAT THE PATIENT'S LABORATORY RESULTS INDICATED THAT THE CAUSE OF DEATH WAS A MYOCARDIAL INFARCTION. THERE IS NO INDICATION THAT THE ARCHITECT C8000 CREATININE RESULTS CAUSED OR CONTRIBUTED TO THE PATIENT DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death CREATININE REAGENT LIST 7D64-20, LOT 63069HW00| CREATININE REAGENT LIST 7D64-20, LOT 63069HW00| CREATININE REAGENT LIST 7D64-20, LOT 63069HW00