BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 873103 · Received June 28, 2007

    Report

    Report Number
    1823260-2007-05675
    Event Type
    Injury
    Date Received
    June 28, 2007
    Date of Event
    June 1, 2007
    Report Date
    June 28, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED THAT A PERITONEAL DIALYSIS PT WAS ADMITTED TO THE FACILITY'S TELEMETRY UNIT FOR SHORTNESS OF BREATH. REPORTER STATED THAT, PRIOR TO ADMISSION, PT WAS BEING TREATED WITH INSULIN BASED ON ELEVATED BLOOD GLUCOSE RESULTS OBTAINED ON THE ADVANTAGE SYSTEM (VALUES NOT PROVIDED). REPORTER NOTED THAT PT'S CONDITION HAD STEADILY DECLINED AND PT'S SPOUSE BROUGHT HIM TO THE HOSPITAL FOR TREATMENT. WHILE HOSPITALIZED, PT'S BLOOD GLUCOSE CONTINUED TO BE MONITORED USING PT'S ADVANTAGE SYSTEM, AT PT'S WIFE'S INSISTENCE. REPORTER STATED THAT A HEALTHCARE PROFESSIONAL IN THE PERITONEAL DIALYSIS CLINIC HAD ADVISED PT THAT THE ADVANTAGE SYSTEM WAS SUITABLE FOR BLOOD GLUCOSE MONITORING, WHILE BEING TREATED WITH EXTRANEAL (A LABELED INTERFERENT FOR THE TEST STRIPS). WHILE HOSPITALIZED, PT'S BLOOD GLUCOSE REPORTEDLY MEASURED 170 MG/DL ON THE ADVANTAGE SYSTEM. AN ADDITIONAL SAMPLE, OBTAINED FROM THE PT, AT THE SAME TIME, REPORTEDLY MEASURED 51 MG/DL IN THE FACILITY'S LAB. BASED ON THE LAB VALUE, PT WAS TREATED WITH DOPAMINE, D5, AND "FLUIDS." NO ADDITIONAL DETAILS OF TREATMENT RECEIVED WERE PROVIDED. REPORTER STATED THAT PT'S CURRENT CONDITION IS "STABLE." AFTER REVIEWING THE EXTRANEAL PACKAGE INSERT, REPORTER PHONED TECHNICAL SUPPORT TO INQUIRE ABOUT THE COMFORT CURVE TEST STRIP CHEMISTRY. TECHNICAL SUPPORT ADVISED THAT PTS BEING TREATED WITH EXTRANEAL SHOULD NOT BE MONITORED USING GDH-PQQ TEST STRIPS, DUE TO POTENTIAL OVERESTIMATION OF BLOOD GLUCOSE RESULTS. TECHNICAL SUPPORT REQUESTED THE RETURN OF PT'S SYSTEM FOR EVALUATION.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR Hospitalization| R PROTONIX 40 MG - ONCE DAILY| ZOFRAN 4 MG - AS NEEDED| ALBUTEROL - EVERY 6 HOURS| HUMULIN R| PLAVIX 75 MG - ONCE DAILY| HALOPERIDOL 5 MG - ONCE DAILY| SIMVASTATIN 80 MG - ONCE DAILY| POTASSIUM CHLORIDE 20 MG - ONCE DAILY| LORATADINE 10 MG - ONCE DAILY| IPRATROPIUM BROMIDE - EVERY 6 HOURS| EZETIMIBE 10 MG - ONCE DAILY| LISINOPRIL 10 MG - ONCE DAILY| TYLENOL - AS NEEDED| LEVOFLOXACIN 750 MG - ONCE DAILY| BACTERIOSTATIC NACL - FLUSH EACH SHIFT| SODIUM CHLORIDE/ADENOSINE 51M - ONCE DAILY| PNEUMOCOCCAL VACCINE 25MCG| INSULIN GLARGINE 10 UNITS| EPOETIN ALFA 10000 UNITS - ONCE WEEKLY| DIANEAL 200 ML/HR| AMBIEN 5 MG - AS NEEDED| PERCOCET 5 MG - AS NEEDED| EXTRANEAL| ALLOPURINOL 150 MG - ONCE DAILY