BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1023397 · Received April 2, 2008

    Report

    Report Number
    1823260-2008-02922
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 14, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT SHE GAVE THE CUSTOMER INSULIN WITH A RESULT OF 434 MG/DL ON THE ADVANTAGE SYSTEM. REPORTER ALLEGED THAT 1.5 HOURS LATER, HE OBTAINED A DISCREPANT BLOOD GLUCOSE RESULT OF 329 MG/DL ON THE SAME ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 48 MG/DL ON THE EMT'S METER WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER INDICATED THAT HE WAS EXPERIENCING SOME SYMPTOMS DURING THE TIME OF TESTING, BUT HIS NURSE WASN'T SURE IF THEY WERE HYPOGLYCEMIC OR HYPERGLYCEMIC. REPORTER STATED THAT THE EMTS TREATED HIM WITH A GLUCOSE INJECTION AND TOOK HIM TO THE HOSP. IT IS NOT PROVIDED IF THERE WERE ANY OTHER ACTIONS TAKEN OR TREATMENT REC'D. 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R LANTUS - 15 UNITS ONCE NIGHTLY| LANTUS - 1 DAY