BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1110454 · Received August 14, 2008

    Report

    Report Number
    1823260-2007-05265
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    May 23, 2007
    Report Date
    June 15, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS GIVING PT WITH HYPERGLYCEMIC SYMPTOMS NOVOLIN 70/30 AT 9:53 (NO TESTS DONE AT THIS TIME). PT HAD HYPOGLYCEMIC SYMPTOMS AT 15:01 WITH BLOOD GLUCOSE RESULT OF 167 MG/DL TAKEN ON THE INFORM SYSTEM; HE WAS TREATED WITH A SMALL AMOUNT OF D50, AND AT 15:P31 A SAMPLE WAS COLLECTED FOR A LAB (RESULT WAS 47 MG/DL). CONTROLS WERE RUN AND IN RANGE. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER, THE TEST STRIPS USED DURING THE INCIDENT HAVE ALREADY BEEN USED; REPLACEMENT 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 549649

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR NITRO PAST EVERY 6 HRS| CARDURA 4MG ONCE DAILY| ZETIA 10MG AT BEDTIME| LOVENOX 40MG DAILY| COLCHICINE 0.5MG DAILY| CLONIDINE 0.2MG 3/DAILY| BARIUM SULFATE| LIPITOR 80MG AT BEDTIME| ASPIRIN 81MG ONCE DAILY| NORVASC 10MG ONCE DAILY| HYDRALAZINE 36MG 3/DAILY| LANTUS DOSE UNK AT BEDTIME| HUMULIN 70/30 DOSE UNK| HUMULIN R 4UNITS| LISINOPRIL 40MG ONCE DAILY| PROTONIX 40MG ONCE DAILY| LASIX 40MG DAILY| MAG-TAB 84MG TWICE DAILY| COREG 25MG TWICE DAILY