BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C-PEPTIDE REAGENT

    MDR report key: 2193630 · Received August 5, 2011

    Report

    Report Number
    1415939-2011-00531
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    May 3, 2011
    Report Date
    June 21, 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
    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 ELEVATED BIORAD CONTROLS WHEN ARCHITECT C-PEPTIDE REAGENT LOT 01711A000 WAS IN USE AFTER CHANGING FROM THE PREVIOUS ARCHITECT REAGENT LOT. THE CUSTOMER STATED THE ARCHITECT C-PEPTIDE CONTROLS WERE WITHIN RANGE, THEN MEASURED THE SEKK EQA SAMPLES AND GENERATED RESULTS THREE TIMES HIGHER THAN THE PEER GROUP FOR THE EQA SAMPLES. 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 I1000SR ANALYZER, LIST# 1L86-01| SEKK EQA SAMPLES