BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C-PEPTIDE REAGENT

    MDR report key: 2301946 · Received October 20, 2011

    Report

    Report Number
    1415939-2011-00654
    Event Type
    Malfunction
    Date Received
    October 20, 2011
    Report Date
    July 12, 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
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 SHIFT HIGH IN BIORAD QUALITY CONTROLS WHEN CLINICAL CHEMISTRY C-PEPTIDE REAGENT LOT 01711A000 WAS IN USE. THE CUSTOMER STATED CLINICIANS QUESTIONED MULTIPLE PATIENT RESULTS, HOWEVER, AFTER REPEATED REQUESTS BY ABBOTT, THE CUSTOMER DID NOT PROVIDE ANY EXAMPLES OF THIS DATA FOR REVIEW. FALSELY ELEVATED RESULTS WERE REPORTED OUT OF THE LAB, HOWEVER, THERE WAS NO KNOWN 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 I200SR, LIST # 3M74-01, SN (B)(4)