BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CLINICAL CHEMISTRY CARBON DIOXIDE ASSAY

    MDR report key: 3786717 · Received May 2, 2014

    Report

    Report Number
    1628664-2014-00088
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    KHS
    PMA / PMN Number
    K060295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE CLINICAL CHEMISTRY CO2 ASSAY PACKAGE INSERT AND THE ARCHITECT SYSTEM OPERATION MANUAL CONTAIN INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. THERE WERE NO RETURNS FROM THE CUSTOMER SITE FOR THIS EVALUATION. CUSTOMERS HAVE BEEN INFORMED THAT THE CLIN CHEM CO2 CALIBRATORS HAVE BEEN RESTANDARDIZED AND ARE TRACEABLE TO THE NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY STANDARD REFERENCE MATERIAL (NIST SRM) 351. THIS WAS INITIATED WITH THE INTRODUCTION OF LOT 31451M500, WHICH THE CUSTOMER IS CURRENTLY USING. A SHIFT OF APPROXIMATELY 1 MMOL/L OR AN AVERAGE OF 4 TO 8% CAN BE SEEN DEPENDING ON EACH INDIVIDUAL LABORATORY. BASED ON THE RESULTS OF THE CURRENT EVALUATION, A PRODUCT MALFUNCTION WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS LOW CLIN CHEM CO2 ASSAY RESULTS BEING GENERATED ON AN ARCHITECT C16000 ANALYZER. THE CUSTOMER STATED THAT INTERNAL QUALITY CONTROLS ARE WITHIN SPECIFICATIONS BUT WITH HIGHER THAN EXPECTED COEFFICIENTS OF VARIATION, BUT THAT PATIENT RESULTS ARE "INTUITIVELY LOW." AN ABBOTT REPRESENTATIVE ON-SITE FOUND THE ASSAY CONFIGURATION TO BE CORRECT AND THE WATER SUPPLY ACCEPTABLE. THE CUSTOMER REPORTS THAT INFORMATION REGARDING DIALYSIS PATIENTS FOUND THAT 50% OF PATIENTS ARE RUNNING BELOW THEIR REFERENCE RANGE AND THAT THEY HAVE SUSPECTED A LOW BIAS FOR THE ASSAY FOR THE PAST MONTH. SEVERAL TRANSPLANT PATIENTS HAVE BEEN RECALLED FOR REPEAT TESTING AND IT WAS STATED THAT SOME TREATMENTS HAVE BEEN DEFERRED (NO FURTHER INFORMATION PROVIDED BY THE CUSTOMER AND NO REPORTS OF ANY ADVERSE IMPACT TO THE PATIENTS). THE CUSTOMER PROVIDED THE FOLLOWING EXAMPLES: 1.) ONE MALE PATIENT GENERATED A CO2 RESULT OF 14 MMOL/L ON (B)(6) 2014. A REPEAT SAMPLE DRAWN THREE HOURS LATER GENERATED A CO2 RESULT OF 25 MMOL/L. THE CLINICAL STATUS OF THIS PATIENT REMAINED UNCHANGED; 2.) ONE MALE PATIENT GENERATED CO2 RESULTS RANGING FROM 21 TO 32 MMOL/L FROM (B)(6) 2014 TO (B)(6) 2015; 3.) ONE MALE PATIENT GENERATED CO2 RESULTS RANGING FROM 16 TO 26 MMOL/L ACROSS THREE ARCHITECT C16000 SYSTEMS FROM (B)(6) 2014; AND 4.) ONE PATIENT GENERATED CO2 RESULTS RANGING FROM 15.2 TO 24 MMOL/L ON TWO ARCHITECT C16000 SYSTEMS (DATE RANGE NOT PROVIDED BY CUSTOMER). THE REMAINING ASSAYS IN THEIR RENAL PROFILE (SODIUM, POTASSIUM, CHLORIDE, UREA AND CREATININE) WERE STABLE. THERE IS NO REPORT OF ANY ADVERSE IMPACT TO PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265075 ARCHITECT CLINICAL CHEMISTRY CARBON DIOXIDE ASSAY CARBON DIOXIDE KHS ABBOTT MANUFACTURING INC 44296UQ07

    Patients

    Seq Age Sex Outcome Treatment
    1 LOTS: 31451M500 AND 32324M500| ARCHITECT C16000 LN:03L77-01 SN: (B)(4)| CLIN CHEM CO2 CALIBRATORS LN:01E64-02| LOTS: 31451M500 AND 32324M500| LOTS: 31451M500 AND 32324M500| CLIN CHEM CO2 CALIBRATORS LN: 01E64-02| ARCHITECT C16000 LN:03L77-01 SN: (B)(4)| ARCHITECT C16000 LN:03L77-01 SN: (B)(4)| CLIN CHEM CO2 CALIBRATORS LN:01E64-02