BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C-PEPTIDE REAGENT

    MDR report key: 2193634 · Received August 5, 2011

    Report

    Report Number
    1415939-2011-00527
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    June 22, 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
    IT
    Reporter Occupation
    OTHER

    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 BIORAD LYPHOCHECK CONTROLS OUT OF RANGE HIGH WHEN ARCHITECT C-PEPTIDE REAGENT LOT 01411B000 WAS IN USE, ALTHOUGH, THE CUSTOMER DID NOT OBSERVE SHIFT IN PATIENT RESULTS. THE CUSTOMER CLEANED THE PROBE AND RECALIBRATED THE C-PEPTIDE ASSAY WHICH DID NOT RESOLVE THE ISSUE. THERE WAS NO IMPACT TO PATIENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C-PEPTIDE REAGENT JKD ABBOTT LABORATORIES 01411B000

    Patients

    Seq Age Sex Outcome Treatment
    1 BIORAD LYPHOCHECK CONTROL LOT 40230| ARCHITECT I1000SR ANALYZER, LIST# 1L86-01