BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1002673 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01387
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 26, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS PT WITH BLOOD GLUCOSE RESULT OF 320 MG/DL OBTAINED ON THE INFORM SYS WITH HYPOGLYCEMIC SYMPTOMS. LAB VALUE OF 18 MG/DL WAS OBTAINED WITHIN 5 MINS OF THE METER VALUE. PT WAS TREATED WITH TWO AMPULES OF "D-50" AS A RESULT OF THE LAB VALUE; SYMPTOMS IMPROVED. 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 550005

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PROVENTIL INHALER AS NEEDED| NEXIUM 40MG TWICE DAILY| D50 INJECTION AS NEEDED| INSTA-GLUCOSE AS NEEDED| APIDRA AS DIRECTED| LOTRIMIN AF 3/DAILY| FORTAZ IV 1GM EVERY 12 HRS| FENTANYL 25MCG INJECTION| HEPARIN 5000UNITS EVERY 8 HRS| GLUCAGEN AS NEEDED| ALBUMIN INFUSION| MINERAL OIL AS NEEDED| AMIKACIN 800MG IV ONCE| FENTANYL 50MCG SYRINGE| FUROSEMIDE 60MG IV| NACL 0.9% IV BOLUS| LANTUS 5UNITS AT BED TIME| FUROSEMIDE 40MG IV| FENTANYL 25MCG PATCH| PERCOCET EVERY 4 HRS| MUCOMYST 600MG 2/DAILY| DIFLUCAN 100MG DAILY| NPH-REGULAR 70/30 4 UNITS