BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT PHOSPHORUS

    MDR report key: 3761108 · Received April 21, 2014

    Report

    Report Number
    1628664-2014-00078
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 1, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS AND A REVIEW OF LABELING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE SAMPLE WAS NOT REQUESTED TO BE RETURNED, DUE TO SAMPLE BEING REPEATED AT ANOTHER LAB WITH A DIFFERENT METHODOLOGY AND WAS CONFIRMED TO MATCH ARCHITECT CSYSTEM RESULT. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4). THE COMPLETE SID IS (B)(6). AN EVALUATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY DEPRESSED PHOSPHORUS RESULT FOR ONE PATIENT ON THE ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED FOR SID (B)(6): ON (B)(6) 05:06 AM, RESULT <0.70 MG/DL ON PLASMA. ON (B)(6), 01:26 PM, RESULT = 0.72 MG/DL ON SERUM. ON (B)(6), 01:52 PM, RESULT = 0.82 MG/DL ON SERUM. REPEATED ON ANOTHER METHOD (ROCHE) AS 0.71 MG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240455 ARCHITECT PHOSPHORUS CLINICAL CHEMISTRY PHOSPHORUS JJE ABBOTT MANUFACTURING INC 81317UN13

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 03L77-01 SN (B)(4)| ARCHITECT C16000 ANALYZER| ARCHITECT C16000 ANALYZER| LN 03L77-01 SN (B)(4)