BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 3900008 · Received June 27, 2014

    Report

    Report Number
    1628664-2014-00126
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMED TROUBLESHOOTING, INCLUDING RECALIBRATION OF REAGENT PROBES, CUVETTE WASH, AND INSPECTION OF THE CUVETTE WASHER AREA. THE CUSTOMER OBSERVED LIQUID REMAINING IN SOME OF THE CUVETTES AND CONFIRMED THERE WAS LEAKAGE IN THE WASH AREA. SERVICE WAS REQUESTED. THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE VACUUM PUMP DIAPHRAGM TO RESOLVE THE ISSUE. THE REPLACED PART WAS NOT AVAILABLE FOR RETURN. A REVIEW OF HISTORICAL DATA REVEALED NO SYSTEMIC ISSUES OR ADVERSE / NON STATISTICAL TRENDS ASSOCIATED WITH THE CUSTOMER'S ISSUE. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES ADEQUATE INFORMATION, TROUBLESHOOTING, AND MAINTENANCE CONCERNING ERRATIC/ DISCREPANT RESULTS; INCLUDING, BUT NOT LIMITED TO, THE TROUBLESHOOTING PERFORMED BY THE CUSTOMER AND THE ABBOTT FSR. BASED ON THE AVAILABLE INFORMATION, A DEFICIENCY OF THE SYSTEM WAS NOT IDENTIFIED. THERE IS NO EVIDENCE TO REASONABLY SUGGEST A MALFUNCTION OCCURRED. THE ISSUE WAS RESOLVED THROUGH STANDARD TROUBLESHOOTING PROCEDURES.

    Description of Event or Problem · 1

    THE CUSTOMER STATED FALSELY ELEVATED CREATININE RESULTS WERE GENERATED ON THE ARCHITECT C16000. A (B)(6) YEAR OLD FEMALE PATIENT (ID # (B)(6)) IN A NURSING HOME HAD AN INITIAL CREATININE RESULT OF 2.3 MG/DL THAT REPEATED 0.8 MG/DL. THE PHYSICIAN WAS NOTIFIED OF THE REPEAT VALUE AND THE PATIENT WAS CONTACTED. A (B)(6) YEAR OLD MALE PATIENT (ID # (B)(6)) HAD AN INITIAL CREATININE RESULT OF 15.7 MG/DL THAT REPEATED 1.0 MG/DL. THE PATIENT WAS BEING EVALUATED FOR HOSPITAL ADMISSION AND HAD A PROLONGED ER VISIT DUE TO THE RESULTS. A (B)(6) YEAR OLD MALE PATIENT (ID # (B)(6)) IN DIAGNOSTIC RADIOLOGY HAD AN INITIAL CREATININE RESULT OF 4.4 MG/DL THAT REPEATED 1.2 MG/DL. THE PHYSICIAN WAS NOTIFIED OF THE REPEAT VALUE AND THE PATIENT WAS CONTACTED. A (B)(6) YEAR OLD MALE CARDIOLOGY PATIENT (ID # (B)(6)) HAD AN INITIAL CREATININE RESULT OF 14.5 MG/DL THAT REPEATED 1.6 MG/DL. THE CUSTOMER STATED DUE TO THE ELEVATED RESULT, THE PHYSICIAN DID NOT USE CONTRAST WHEN PERFORMING A CAT SCAN. NO ADVERSE OUTCOMES WERE REPORTED FOR THE ABOVE MENTIONED PATIENTS. NO FURTHER PATIENT INFORMATION COULD BE OBTAINED.

    Description of Event or Problem · 1

    PATIENTS T59050 AND W60185 WERE SENT TO THE ER BASED ON THE ELEVATED CREATININE VALUE. THE PATIENTS WERE NOT EVALUATED IN THE ER AS THE PHYSICIAN RECEIVED THE CORRECTED VALUE AND CONTACTED THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377951 ARCHITECT C16000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 CREATININE REAGENT| CREATININE REAGENT| CREATININE REAGENT