BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE H

    MDR report key: 251390 · Received November 23, 1999

    Report

    Report Number
    1823260-1999-00156
    Event Type
    Injury
    Date Received
    November 23, 1999
    Date of Event
    November 8, 1999
    Report Date
    November 8, 1999
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IN POST OPERATION WARD. TESTED BLOOD GLUCOSE WITH SUSPECT DEVICE AND BLOOD GLUCOSE WAS 200-210 MG/DL. DID A LAB BLOOD GLUCOSE AND IT WAS BETWEEN 380-400 MG/DL. THE NURSE TESTED THE PT'S BLOOD GLUCOSE ON ANOTHER SUSPECT DEVICE AND IT WAS 200-210 MG/DL, SO SHE DREW BLOOD FOR ANOTHER LAB BLOOD GLUCOSE. THE LAB BLOOD GLUCOSE WAS 386 MG/DL. THE PT WAS TREATED WITH INSULIN IV BASED OFF OF THE 1ST SUSPECT DEVICE READING. THE PT WAS THEN TRANSFERRED TO INTENSIVE CARE UNIT. THE NURSE REPORTS A DELAY IN TREATMENT WHILE TRYING TO DETERMINE WHICH BLOOD GLUCOSE READING WAS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE H BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 522467

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention