BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX® LANCET DEVICE

    MDR report key: 1874226 · Received October 19, 2010

    Report

    Report Number
    1823260-2010-06207
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE SOFTCLIX DEVICE. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED SEVERE HYPOGLYCEMIA. THIS OCCURRED 3 TIMES WHEN PT FIRST STARTED INFUSION DEVICE THERAPY. PT WOKE IN THE MIDDLE OF THE NIGHT AND BLOOD GLUCOSE WAS 40 MG/DL. PT WAS SWEATY AND SHAKY AND UNABLE TO GET OUT OF BED. TARGET BLOOD GLUCOSE IS 120 MG/DL. PT TYPICALLY EATS SNACK BEFORE BED, AND PT COULD NOT RECALL IF SHE GAVE A BOLUS. PT'S MOTHER BROUGHT ORANGE JUICE AS TREATMENT FOR HYPOGLYCEMIA. PT WENT BACK TO BED AND BLOOD GLUCOSE WAS NORMAL THE NEXT DAY. PT REPORTED SHE WOULD NOT HAVE BEEN ABLE TO TREAT HERSELF. HEALTH PROFESSIONAL ADJUSTED BASAL RATES AND PARAMETERS FOR BOLUS CALCULATIONS, AND THIS HAS NOT HAPPENED SINCE PT FIRST STARTED INFUSION DEVICE. NO PRODUCTS WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX® LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS NA BAS182

    Patients

    Seq Age Sex Outcome Treatment
    1