BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE

    MDR report key: 296349 · Received September 14, 2000

    Report

    Report Number
    296349
    Event Type
    Malfunction
    Date Received
    September 14, 2000
    Date of Event
    September 11, 2000
    Report Date
    September 12, 2000
    Manufacturer
    BAYER CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PT HAD A BLOOD GLUCOSE METER RESULT OF 129 AT 0600. ROUTINE BLOODWORK DONE AT 0700 REVEALED A BLOOD SUGAR OF 36. PT AT THAT TIME WAS UNRESPONSIVE AND RECEIVED D50 WITH AN INCREASE IN RESPONSIVENESS. TRANSFERRED TO ICU. PT WITH HISTORY OF DM; ON AMARYL 1MG DAILY AT 0730 (NO DOSE GIVEN 9/11/00), HISTORY OF CONGESTIVE HEART FAILURE AND RENAL INSUFFICIENCY WITH QUESTIONABLE CONTRIBUTION TO HYPOGLYCEMIA. HGB 8.4 HCT 24.9. CONTROL DONE 11-7 SHIFT - TIME UNKNOWN. RANGE 95-115 RESULT 105. TEST STRIP LOT #0B05JC CODE #F-5 EXPIRES 8/2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE BGM MACHINE CFR BAYER CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other