BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 2555039 · Received May 1, 2012

    Report

    Report Number
    1628664-2012-00266
    Event Type
    Malfunction
    Date Received
    May 1, 2012
    Date of Event
    April 10, 2012
    Report Date
    April 11, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM THE CUSTOMER INDICATED THAT THE SAMPLES TESTED ON THE I-STAT WERE FROM FINGERSTICKS; WHILE SAMPLES RAN ON THE ARCHITECT C8000 WERE DRAWN FROM A PORT LINE. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED RELATED TO THE CUSTOMER ISSUE. THE ARCHITECT C8000 AND THE I-STAT OPERATIONS MANUALS WERE REVIEWED AND WERE FOUND TO ADEQUATELY ADDRESS THE ISSUE. NO PRODUCT DEFICIENCY OR MALFUNCTION WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4) - (NO CONSEQUENCES OR IMPACT TO PATIENT); (B)(4) - (INCORRECT OR INADEQUATE TEST RESULT). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THEY HAVE A PATIENT WHOSE ARCHITECT POTASSIUM RESULTS ARE HIGH COMPARED WITH THE I-STAT. ON (B)(6) 2012 AT 2225: 7.9 MMOL/L ON ARCHITECT VS. 5.1 MMOL/L AT 2000 ON I-STAT; ON (B)(6) 2012 AT 0001: 8.8 MMOL/L ON ARCHITECT; ON (B)(6) 2012 AT 0228: 4.3 MMOL/L ON ARCHITECT VS. 4.1 MMOL/L AT 0316 ON I-STAT; ON (B)(6) 2012 AT 0438: 6.7 MMOL/L ON ARCHITECT; ON (B)(6) 2012 AT 0655: 7.9 MMOL/L ON ARCHITECT; ON (B)(6) 2012 AT 0821: 6.9 MMOL/L ON ARCHITECT VS. 4.0 MMOL/L AT 1010 ON I-STAT; ON (B)(6) 2012 AT NOON: 4.1 MMOL/L ON I-STAT; THE DRAW TIMES WERE NOT THE SAME FOR ARCHITECT VS. I-STAT. SAMPLES FOR LAB WERE ALL GREEN TOP LITHIUM HEPARIN DRAWN THROUGH A PORT WITH SALINE USED TO FLUSH. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM JJE ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT ICT MODULE LN 9D28-03| ARCHITECT ICT MODULE LN 9D28-03