BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 958383 · Received December 3, 2007

    Report

    Report Number
    1823260-2007-10421
    Event Type
    Injury
    Date Received
    December 3, 2007
    Date of Event
    November 7, 2007
    Report Date
    December 3, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 268 MG/DL ON HIS ADVANTAGE SYSTEM AND TAKING 3 UNITS OF NOVOLOG INSULIN BASED ON THAT READING AROUND 9 PM. HE STATED THAT HE AWOKE WITH HYPOGLYCEMIC SYMPTOMS AT 1:30 AM, THAT HE FELL AND STARTED SEIZING WHILE TRYING TO GET SOME OJ. HE REPORTED THAT HIS FRIEND OBTAINED A READING OF 21 MG/DL, CALLED 911, AND THEN TRIED TREATING HIM WITH GLUCOSE PASTE. REPORTER STATED THAT THE EMT'S OBTAINED A READING OF 21 MG/DL AND TREATED HIM WITH D50. HE THEN REPORTED THAT ALMOST 1 HOUR LATER, THEY RETESTED HIM AND OBTAINED A 144 MG/DL ON THEIR METER COMPARED BACK TO BACK WITH A RESULT OF 519 MG/DL ON HIS METER. NO OTHER ACTION OR TREATMENT RESULTED. 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 549950

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention NOVOLOG - 5 YEARS SLIDING SCALE| LANTUS - 5 YEARS 15 UNITS ONCE DAILY