BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1062369 · Received June 18, 2008

    Report

    Report Number
    1823260-2008-04824
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    June 8, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A DISCREPANT BLOOD GLUCOSE RESULT OF 205 MG/DL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 88 MG/DL ON THE HOSPITAL'S SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER INDICATED THAT SHE WAS EXPERIENCING SOME HYPOGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. REPORTER STATED SHE WAS GIVEN JUICE AT THE HOSPITAL WHICH SHE CONSUMED ON HER OWN. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. 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 550540

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR LANTUS - 5 YEARS 15 UNITS ONCE DAILY| NOVOLOG - 1 YEAR| NOVOLIN - 1 YEAR| LEXAPRO - 9 MONTHS - 10MG ONCE DAILY