BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C-PEPTIDE REAGENT

    MDR report key: 2193925 · Received August 5, 2011

    Report

    Report Number
    1415939-2011-00529
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    June 16, 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
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONSEQUENCES OR IMPACT TO PATIENT - (B)(4). HIGH TEST RESULTS - (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 ELEVATED VALUES FOR SEKK EQA SAMPLES WHEN TESTED WITH ARCHITECT C-PEPTIDE REAGENT LOT (B)(4). THE CUSTOMER STATED ABBOTT CONTROLS WERE WITHIN SPECIFICATION, THEREFORE, THE CUSTOMER RECALIBRATED THE ASSAY AND RE-RAN THE EQA SAMPLES AND GENERATED REPEAT ELEVATED RESULTS. 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 03610K000

    Patients

    Seq Age Sex Outcome Treatment
    1 SEKK EQA SAMPLES| ARCHITECT I1000SR ANALYZER, LIST# (B)(4)