BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOTAL BILIRUBIN BPD PRECICAL, PRECITROL-A & PRECITROL-N CONT

    MDR report key: 213001 · Received March 2, 1999

    Report

    Report Number
    1823260-1999-00020
    Event Type
    Other
    Date Received
    March 2, 1999
    Date of Event
    August 28, 1998
    Report Date
    March 1, 1999
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT ALLEGED THAT THEY OBSERVED 10% POSITIVE BIAS IN THE HIGHER RANGE FOR TOTAL BILIRUBIN "DPD" VALUES IN NEONATES. THE ACCOUNT PERCEIVES THAT THIS HAS BEEN AN ONGOING ISSUE WITH THE ANALYZER AND THE T BILIRUBIN REAGENT, AND THAT THEY WERE NOT ALERTED OF THIS PROBLEM IN A TIMELY MANNER. CUSTOMERS HAVE BEEN NOTIFIED OF THE BIAS FOR TOTAL BILIRUBIN "DPD" CAUSED WITH THE NEW STANDARDIZATION. THEY WERE ALSO NOTIFIED OF REVISED VALUE ASSIGNMENTS FOR PRECICAL AND PRECITROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL BILIRUBIN BPD PRECICAL, PRECITROL-A & PRECITROL-N CONT LABORATORY CALIBRATOR & CONTROL REAGENT CIG ROCHE DIAGNOSTICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other