BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY PHENOBARBITAL

    MDR report key: 2893536 · Received January 2, 2013

    Report

    Report Number
    1628664-2013-00002
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    November 19, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJC
    Removal / Correction Number
    RCR 1628664-11/19/12-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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.

    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 PHENOBARBITAL QUALITY CONTROL CVS WERE HIGH FOR ALL THREE LEVELS ON AN ARCHITECT C4000 ANALYZER. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631 CLINICAL CHEMISTRY PHENOBARBITAL JJC ABBOTT MANUFACTURING INC 62299UN12

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH C4000 LN 02P24-01, LN C460538