BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY PHENOBARBITAL

    MDR report key: 2991689 · Received March 6, 2013

    Report

    Report Number
    1628664-2013-00051
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 5, 2013
    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
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 STATED AN ARCHITECT C8000 ANALYZER GENERATED DISCREPANT RESULTS FOR PHENOBARBITAL QUALITY CONTROLS WHEN PHENOBARBITAL REAGENT LOT 85773UN12 WAS IN USE. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96176 CLINICAL CHEMISTRY PHENOBARBITAL LGQ ABBOTT MANUFACTURING INC 85773UN12

    Patients

    Seq Age Sex Outcome Treatment
    1 LN 01G06-01, SN (B)(4)| ARCHITECT C8000 ANALYZER