BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1771202 · Received February 18, 2008

    Report

    Report Number
    1823260-2008-01642
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    January 30, 2008
    Report Date
    February 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES PATIENT REPORTEDLY RECEIVED RESULT OF 68 MG/DL ON THE INFORM SYSTEM AND 31 MG/DL ON A LAB VALUE WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 550021

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR SODIUM CHLORIDE FLUSH - AS NEEDED| EPOGEN - 1000 UNITS 3/WEEKLY| CATAPRES - 0.3MG EVERY 4 HRS FOR BP>160| ATROPINE - 0.5MG AS NEEDED| PROTONIX - 40MG TWICE DAILY| CLOPIDOGREL - 75MG DAILY| LIPITOR - 50MG ONCE DAILY| LEVOTHYROXINE - 50MCG DAILY| NOVOLIN SLIDING SCALE| CARVEDILOL - 12.5MG 2/DAILY| PHENERGAN - 12.5MG EVERY 6 HRS| NITROGLYCERIN - 0.4MG AS NEEDED| MILK OF MAGNESIA - 30ML| DILAUDID IV - 1MG AS NEEDED| HYDRALAZINE HCL - 20MG EVERY 4 HRS| GLUCAGON - 1MG AS NEEDED BG<70| DEXTROSE - DOSE UNK| MAALOX - 30ML AS NEEDED| CHANTIX - 1MG TWICE DAILY| SEVELAMER - 800MG 3/DAILY| CALCIUM ACETATE - 667MG 3/DAY| COMPLEX C FOLIC ACID DAILY| NITROGLYCERIN - 1 INCH EVERY 6 HOURS| ASPIRIN - 325MG DAILY| ACETAMINOPHEN - 650MG AS NEEDED| REGLAN - 10MG 3/DAILY| DEXTROSE - 50% 50ML AS NEEDED