BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1810304 · Received August 20, 2010

    Report

    Report Number
    1823260-2010-05003
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    August 15, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE OBTAINING THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM: 578 MG/DL AT 8:05 AM 205 MG/DL AT 8:15 AM HI (GREATER THAN 600 MG/DL) AT 8:21 AM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED BY BAXTER (B)(4) ON (B)(6) 2010 FROM (B)(6) HOSPITAL ADVISING ON (B)(6) 2010 AN AQUARIUS MACHINE REPORTEDLY FINISHED THE PROGRAMMED TREATMENT IN TWO HOURS VERSUS THE TEN HOUR PROGRAMMED TIME. THE MEDICAL TEAM WAS INFORMED, AS THE PATIENT'S BLOOD PRESSURE DROPPED TO AN UNKNOWN LEVEL. THE PATIENT WAS GIVEN 10ML/KG OF FLUID TO CORRECT THE DROP IN BLOOD PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551179

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR NOVOLOG (SLIDING SCALE)| STEROIDS