BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK INFORM TEST STRIPS

    MDR report key: 1060212 · Received June 16, 2008

    Report

    Report Number
    1823260-2008-04743
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN FOREIGN COUNTRY.

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT'S BLOOD GLUCOSE WAS MEASURED, USING THE INFORM SYSTEM, WITH A RESULT OF 352 MG/DL. BASED ON THIS VALVE, PATIENT WAS REPORTEDLY TREATED WITH 20 UNITS OF ACTRAPID INSULIN. FOUR HOURS LATER, PATIENT WAS REPORTEDLY EXHIBITING SYMPTOMS OF HYPOGLYCEMIA. AT THIS TIME, PATIENT'S BLOOD GLUCOSE WAS RETESTED ON THE INFORM SYSTEM WITH A RESULT OF 229 MG/DL. NO TREATMENT WAS REPORTED. REPORTER STATED THAT, 10-20 MINUTES LATER, AN ADDITIONAL SAMPLE WAS OBTAINED FROM THE PATIENT AND SENT TO THE FACILITY'S LAB FOR TESTING. APPROXIMATELY 1 HOUR LATER, THE LAB REPORTED THAT PATIENT'S BLOOD GLUCOSE WAS LESS THAN 20 MG/DL. REPORTER NOTED THAT PATIENT WAS RETESTED, ON A DIFFERENT INFORM SYSTEM, WITH A RESULT OF 17 MG/DL. PATIENT WAS THEN TESTED ON THE SUSPECT INFORM SYSTEM WITH A RESULT OF 311 MG/DL. REPORTER STATED THAT PT WAS TREATED WITH GLUCOSE. NO ADDITIONAL TREATMENT WAS REPORTED. PATIENT WAS REPORTED TO BE RECOVERED. THE SUSPECT PRODUCT WAS NOT RETURNED TO THE MFR FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK INFORM TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - NA NBW ROCHE DIAGNOSTICS 549857

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention