BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C-PEPTIDE REAGENT

    MDR report key: 2194243 · Received August 6, 2011

    Report

    Report Number
    1415939-2011-00522
    Event Type
    Malfunction
    Date Received
    August 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JKD
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1415939-7/11/11-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE ARCHITECT C-PEPTIDE FALSELY ELEVATED QUALITY CONTROLS AND PATIENT RESULTS WAS DUE TO A NEW ANTIBODY LOT USED IN THE MANUFACTURING OF THE C-PEPTIDE MICROPARTICLE AND/OR CONJUGATE REAGENTS. ABBOTT ISSUED A PRODUCT RECALL LETTER TO ALL CUSTOMERS WITH INSTRUCTIONS TO DISCARD AND DESTROY ANY REMAINING INVENTORY OF THE AFFECTED LOTS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A HIGHER THAN EXPECTED ARCHITECT C-PEPTIDE RESULT FOR A DIABETIC PATIENT WHICH WAS INCONSISTENT WITH THE PATIENT'S INSULIN VALUES. THE CUSTOMER STATED THE C-PEPTIDE QUALITY CONTROLS WERE WITHIN 1SD, HOWEVER, EXTERNAL CONTROLS WERE HIGH. THE CUSTOMER PERFORMED A SERIES OF DILUTIONS TO RULE OUT POSSIBLE HETEROPHILIC ANTIBODY INTERFERENCE AND THE RESULTS OBTAINED CONFIRMED THE INITIAL ELEVATED RESULT. THE CUSTOMER CALLED THE PATIENT TO COME BACK FOR A SECOND BLOOD DRAW (NO DATA PROVIDED) HOWEVER, THE CUSTOMER RECALIBRATED THE ASSAY BETWEEN THE FIRST AND SECOND BLOOD DRAW WITH NO CHANGE IN THE CONTROL VALUES. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C-PEPTIDE REAGENT JKD ABBOTT LABORATORIES 01711A000

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT (B)(4) ANALYZER, LIST # (B)(4)