BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1031833 · Received March 21, 2008

    Report

    Report Number
    1823260-2008-03402
    Event Type
    Injury
    Date Received
    March 21, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A DISCREPANT BLOOD GLUCOSE RESULT OF 199 MG/DL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 35 MG/DL ON THE EMT'S SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER INDICATED THAT SHE WAS EXPERIENCING SOME HYPOGLYCEMIC SYMPTOMS OF DIZZINESS, SHAKINESS, AND DISORIENTATION DURING THE TIME OF TESTING. REPORTER STATED THAT THE EMTS TREATED HER WITH GLUCOSE AND IV AND TOOK HER TO THE HOSPITAL WHERE A 71 MG/DL RESULT WAS OBTAINED AND SHE WAS GIVEN FOOD. NO OTHER ACTIONS WERE REPORTEDLY 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 550519

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention 70/30 AND R - 2 YEARS