BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY PHENOBARBITAL

    MDR report key: 2863526 · Received December 10, 2012

    Report

    Report Number
    1628664-2012-00505
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 12, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    LGQ
    Removal / Correction Number
    1628664-11/19/12-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION DETERMINED THREE LOTS OF PHENOBARBITAL REAGENT (52803UN12, 62299UN12, AND 85773UN12) HAVE EXHIBITED INCREASED IMPRECISION ASSOCIATED WITH THE AGING OF THE REAGENTS. THE ISSUE IS DRIVEN BY FLOCCULATION IN THE R2 REAGENT. CUSTOMERS HAVE BEEN INSTRUCTED TO DISCONTINUE USE OF THESE THREE LOTS AND DESTROY ANY REMAINING INVENTORY. A REPLACEMENT LOT WITH REDUCED DATING IS AVAILABLE TO CUSTOMERS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FLUCTUATIONS IN CALIBRATION FOR PHENOBARBITAL ON AN ARCHITECT C8000 ANALYZER. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY PHENOBARBITAL LGQ ABBOTT MANUFACTURING INC 85773UN12

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH C8000: LN 01G06-01, SN (B)(4)