BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C16000 SYSTEM

    MDR report key: 2162336 · Received July 14, 2011

    Report

    Report Number
    1628664-2011-00531
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JLB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONSEQUENCES OR IMPACT TO PATIENT. LOW TEST RESULTS. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    REFER TO RESULT OF INVESTIGATION BELOW. TO INVESTIGATE THE CUSTOMER'S ISSUE, WE REVIEWED THE COMPLAINT TEXT, THE SYSTEM LOGS, CUSTOMER RETURNED DATA, THE INSTRUMENT HISTORY, AND ARCHITECT SYSTEM LABELING. NO SINGLE DEFINITIVE CAUSE COULD BE DETERMINED DUE TO INSUFFICIENT DATA. THE CUSTOMER'S RETURNED DATA CONFIRMED ALL THE CK RESULTS GENERATED FOR (B)(6) INCLUDING THE SUSPECT RESULT OF <70.0 U/L USING THE 1:10 DILUTION ON (B)(6) 2011. ADDITIONALLY, THE CK RESULTS FOR THE STANDARD AND 1:10 DILUTION WERE FLAGGED <OR>. FLAGS PROVIDE ADDITIONAL INFORMATION ABOUT A RESULT AND INDICATE THE USER MAY NEED TO REVIEW THE RESULT PER THE ARCHITECT OPERATIONS MANUAL. WE WERE NOT ABLE TO OBTAIN THE FULL SET OF SYSTEM LOGS; THEREFORE, WE ARE NOT ABLE TO DETERMINE IF AN ISSUE WITH THE DILUTION OCCURRED. THE HISTORICAL DATA REVIEW FOR THE CUSTOMER'S ARCHITECT C16000 FOUND NO OTHER COMPLAINTS HAVE BEEN REPORTED, AND THERE HAS BEEN NO RECURRENCE OF ISSUES WITH CK DILUTION RESULTS. A REVIEW OF COMPLAINTS AND QUALITY METRICS DID NOT IDENTIFY AN ADVERSE TREND RELATED TO THE CUSTOMER'S ISSUE. LABELING IN THE ARCHITECT SYSTEM OPERATIONS MANUAL AND CK PACKAGE INSERT PROVIDE SUFFICIENT INFORMATION IN REGARDS TO STANDARD, AUTOMATED, AND MANUAL DILUTIONS. ADDITIONALLY, THE MANUAL PROVIDES DESCRIPTIONS OF PATIENT FLAG RESULTS. BASED UPON THE DATA AVAILABLE AND THE RESULTS OF THIS EVALUATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A FALSELY DECREASED CREATINE KINASE (CK) RESULT WAS GENERATED ON THE ARCHITECT C16000 ANALYZER. A PATIENT GENERATED A CK RESULT OF >4267.0 U/L BUT THE 1:10 AUTODILUTED RESULT WAS <70.0 U/L. THE CUSTOMER MANUALLY DILUTED THE SAMPLE 1:20 WITH A RESULT OF 6129.6 U/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C16000 SYSTEM JLB ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT CK LIST # 7D63 LOT # 98767UN11| ARCHITECT CK LIST # 7D63 LOT # 98767UN11