BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1822732 · Received September 1, 2010

    Report

    Report Number
    1823260-2010-05184
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 9, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CRACKS WERE SEEN ON THE BLUE LUER-LOCK CAPS ATTACHED DIRECTLY TO THE DEVICE. THESE CRACKS LED TO LEAKAGE; THEREFORE, THE PATIENTS (NEONATES) WERE NOT FED WITH THE TOTAL AMOUNT OF LIQUID INTENDED. IF THE PATIENT DOES NOT GET ENOUGH LIQUID, THERE IS A DANGER OF HYPERGLYCEMIA.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 198 MG/DL AND 103 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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 551278

    Patients

    Seq Age Sex Outcome Treatment
    1 086 YR