BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 2757773 · Received September 13, 2012

    Report

    Report Number
    1181121-2012-00001
    Event Type
    Other
    Date Received
    September 13, 2012
    Report Date
    September 11, 2012
    Product Code
    GHH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE BOTTLE OF FISHER BRAND SUN-DEX 50 GLUCOSE TOLERANCE TEST BEVERAGE WAS OPENED IN A QUEST DIAGNOSTICS PT SERVICE CENTER AND PARTIALLY CONSUMED PRIOR TO SEEING FOREIGN MATERIAL SUSPENDED IN THE BEVERAGE ON THE INTERIOR OF THE BOTTLE. THE BLACK COLORED MATERIAL WAS 0.4CM IN LENGTH AND APPROX 1MM IN THICKNESS. ADDITIONALLY THE COMPLAINT BOTTLE WAS NOT PRINTED WITH AN INK-JETTED LOT NUMBER OR EXPIRATION DATE. DEVICE MANUFACTURE DATE: 04/2012. OTHER REMARKS: THE ROOT CAUSE FOR THE SOURCE OF THE MATERIAL REMAINS UNDER INVESTIGATION, 100% VISUAL INSPECTION OF THE BOTTLES PRIOR TO FILLING HAS BEEN IMPLEMENTED AS A MODE OF CONTROL FOR THE FOREIGN MATERIAL. A CORRECTIVE ACTION HAS BEEN IMPLEMENTED FOR THE MISSING LOT AND EXPIRATION DATE ADDRESSING THE PREVENTIVE MAINTENANCE FOR THE PHOTO EYE ASSOCIATED WITH THE APPLICATION OF THE LOT AND EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE GHH

    Patients

    Seq Age Sex Outcome Treatment
    1