BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1022506 · Received March 31, 2008

    Report

    Report Number
    1823260-2008-02894
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 211 MG/DL ON THE ADVANTAGE SYSTEM WHILE EXPERIENCING THE SYMPTOMS OF BEING DISORIENTED, LIGHT-HEADED AND IRRITABLE. REPORTER STATED THAT HE DROVE HIMSELF TO THE HOSPITAL AND FORTY-FIVE MINUTES LATER, A RESULT OF 27 MG/DL WAS OBTAINED ON THE HOSPITAL SYSTEM. REPORTER STATED HE WAS GIVEN A SALINE IV WITH GLUCOSE AND THEN SODA, JUICE AND FOOD AS OTHER LOW READINGS WERE OBTAINED ON THE HOSPITAL SYSTEM. REPORTER ALSO ALLEGED THAT WHILE HE WAS IN THE HOSPITAL, A DISCREPANT BLOOD GLUCOSE RESULT OF 300 MG/DL WAS OBTAINED ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH RESULT OF 27 MG/DL ON THE HOSPITAL'S SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549927

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R GLIPIZIDE - 5 YEARS / 10MG ONCE DAILY