BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 983556 · Received January 23, 2008

    Report

    Report Number
    1628664-2008-00021
    Event Type
    Malfunction
    Date Received
    January 23, 2008
    Date of Event
    December 29, 2007
    Report Date
    December 29, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REP FOUND THE CABLE TO THE LAMP WAS DAMAGED BY THE RV CAROUSEL GEAR. A MALFUNCTION OF THE LAMP DUE TO THE CABLE GETTING CAUGHT IN THE RV CAROUSEL GEAR WHEN THE LAMP WAS LAST REPLACED CAUSED THE ISSUE OBSERVED BY THE CUSTOMER. THE FIELD SERVICE REP REPLACED THE LAMP LAND REMINDED THE CUSTOMER TO WATCH FOR LOOSE CABLES DURING INSTALLATION OF THE LAMP. THE ABBOTT ARCHITECT SYSTEM OPERATIONS MANUAL ((PN 96196-107) 2006) DOES NOT PROVIDE SPECIFIC LABELING RELATED TO THE LAMP CABLE GETTING CAUGHT IN THE RV CAROUSEL GEAR BUT IT DOES PROVIDE THE FOLLOWING INFORMATION RELATED TO THE LAMP A POTENTIAL CAUSE FOR THE CUSTOMER'S OBSERVATION AS WELL AS OTHER RELEVANT LABELING: UNDER SECTION 7 OPERATIONAL PRECAUTIONS AND LIMITATIONS, LIMITATIONS OF RESULT INTERPRETATION STATES THE FOLLOWING: ASSAY RESULTS MUST BE USED WITH OTHER CLINICAL DATA, FOR EXAMPLE, SYMPTOMS, OTHER TEST RESULTS, PATIENT HISTORY, CLINICAL IMPRESSIONS, INFO AVAILABLE FROM CLINICAL EVALUATION, AND OTHER DIAGNOSTIC PROCEDURES. ALL DATA MUST BE CONSIDERED FOR PATIENT CARE MANAGEMENT. IF ASSAY RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. THE ARCHITECT SYSTEM HAS BEEN VALIDATED FOR ITS INTENDED USE. HOWEVER, ERRORS CAN OCCUR DUE TO POTENTIAL OPERATOR ERRORS AND THE ARCHITECT SYSTEM TECHNOLOGY LIMITATIONS. UNDER SECTION 10 TROUBLESHOOTING AND DIAGNOSTICS THE OPERATIONS MANUAL PROVIDES THE FOLLOWING AS PROBABLE CAUSE FOR THE CUSTOMER'S OBSERVATION: ERRATIC RESULTS, POOR PRECISION - PHOTOMETRIC RESULTS (C SYSTEM): LAMP IS NOT PERFORMING AS EXPECTED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED AN ARCHITECT C8000 CREATININE RESULT OF 5.5 MG/DL. THE SPECIMEN WAS REPEATED ON ANOTHER ANALYZER WITH A CREATININE OF 1.1MG/DL. A CORRECTED REPORT WAS SENT TO THE PHYSICIAN BASED ON THE REPEAT TESTING. ADDITIONALLY, THE ARCHITECT C8000 ANALYZER WAS GENERATING ERROR CODES 1053, UNABLE TO CALCULATE RESULT, RATE REACTION LINEARITY FAILURE AND ERROR 1051, UNABLE TO CALCULATE RESULT, ABSORBANCE EXCEEDED OPTICAL LIMITS FOR ALKALINE PHOSPHATASE, TOTAL BILIRUBIN AND CREATININE. IT IS UNK IF THE ARCHITECT C8000 CREATININE OF 5.5 MG/DL HAD AN ERROR CODE ASSOCIATED WITH IT. SERVICE WAS REQUESTED FOR THE ARCHITECT C8000 ANALYZER. NO IMPACT NO PT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CC CREATININE| LIST 7D64-20