BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C-PEPTIDE REAGENT

    MDR report key: 2194245 · Received August 6, 2011

    Report

    Report Number
    1415939-2011-00532
    Event Type
    Malfunction
    Date Received
    August 6, 2011
    Report Date
    June 30, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): HIGH TEST RESULTS. 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 FALSELY ELEVATED ARCHITECT C-PEPTIDE PATIENT RESULT WHEN REAGENT LOT 00110L000 WAS IN USE. THE CUSTOMER WAS PERFORMING A CORRELATION BETWEEN THE LUMIPULSE F METHOD AND THE ARCHITECT C-PEPTIDE ASSAY AND OBSERVED THE DISCREPANT RESULT FOR A TYPE 1 DIABETIC PATIENT SAMPLE. ANOTHER SAMPLE FROM THE SAME PATIENT WAS TESTED AND A REPEAT ELEVATED RESULT WAS GENERATED EVEN AFTER CENTRIFUGATION OF THE SAMPLE. THE CUSTOMER ALSO TESTED ALIQUOT SAMPLES FROM THE SAME PATIENT WHICH WERE COLLECTED BEFORE AND AFTER A MEAL. THE CUSTOMER ALSO OBSERVED POOR DILUTION LINEARITY WITH THE SUSPECT SAMPLE, THEREFORE, THE CUSTOMER DECIDED THERE WAS A HIGH POSSIBILITY OF NON SPECIFIC REACTION OF THE DIABETIC PATIENT SAMPLE WITH THE ARCHITECT C-PEPTIDE ASSAY. 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 00110L000

    Patients

    Seq Age Sex Outcome Treatment
    1 LUMIPULSE F C-PEPTIDE ASSAY| ARCHITECT I1000SR ANALYZER, LIST # 1L86-01