BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1743008 · Received June 26, 2007

    Report

    Report Number
    1823260-2007-05586
    Event Type
    Malfunction
    Date Received
    June 26, 2007
    Date of Event
    June 12, 2007
    Report Date
    June 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED CUSTOMER HAD DISCREPANT BLOOD GLUCOSE VALUES ON HIS ADVANTAGE SYSTEM WHEN BACK TO BACK TESTING WAS PERFORMED ON THREE DIFFERENT DAYS. REPORTER STATED CUSTOMER TESTED 512 MG/DL VERSUS 142 MG/DL ON ONE PARTICULAR DAY, 523 MG/DL VERSUS 166 MG/DL ON A DIFFERENT DAY, AND 462 MG/DL VERSUS 108 MG/DL ON A THIRD DAY WHEN THE COMPARATIVE NUMBERS WERE TAKEN 1 MINUTE APART ON THE SYSTEM. REPORTER INDICATED CUSTOMER TAKES INSULIN ON A SLIDING SCALE BASED ON THE READINGS AND WAS NOT EXPERIENCING ANY HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF THE TESTING. IT WAS STATED CUSTOMER DOSED INSULIN ON A SLIDING SCALE BASED ON THE VALUES OF 142, 166, AND 108 MG/DL HOWEVER, NO OTHER ACTIONS OR TREATMENT REPORTED. 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 549621

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR HYDROCHLOROTHIAZIDE 2 YRS - 12.5MG ONCE DAILY| ALTACE 2 YRS - 10MG ONCE DAILY| LANTUS 20 YRS - 18UN ONCE DAILY| WELLBUTRIN 2 YRS - 100MG TWICE DAILY| THYROXINE >10 YRS - 112MICROGRAMS ONCE DAILY| HUMALOG 20 YRS - SLIDING SCALE| EXELON 1.5 YRS - 6MG TWICE DAILY| NAMENDA 1.5 YRS - 10MG TWICE DAILY