BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT PHOSPHORUS

    MDR report key: 3936205 · Received July 15, 2014

    Report

    Report Number
    1628664-2014-00139
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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, A REVIEW OF LABELING AND REAGENT TESTING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. THE TESTING PERFORMED FOUND THAT ALL QUALITY CONTROL AND PATIENT SAMPLES WERE WITHIN THE EXPECTED RANGES. 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). AN EVALUATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED PHOSPHORUS RESULT FOR ONE PATIENT ON THE ARCHITECT C16000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL 4.61MMOL/L, REPEAT = 0.78 (REF RANGE 0.8-1.5). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412237 ARCHITECT PHOSPHORUS CLINICAL CHEMISTRY PHOSPHORUS JJE ABBOTT MANUFACTURING INC 14833UN13

    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)