BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX® PLUS LANCET DEVICE

    MDR report key: 1832663 · Received September 13, 2010

    Report

    Report Number
    1823260-2010-05407
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 2, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE LANCET PROTRUDES BEYOND THE END-CAP OF THE SOFTCLIX PLUS LANCET DEVICE. NO ADVERSE EVENT ASSOCIATED WITH THE ALLEGED MALFUNCTION WAS REPORTED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, PHYSICIAN REPORTED PT WAS ADMITTED TO HOSPITAL ON (B)(6) 2010 WITH METABOLIC KETOACIDOSIS. PT RECEIVED AN OCCLUSION (E4) ERROR WHEN HE TRIED TO BOLUS PRIOR TO HOSPITALIZATION. PHYSICIAN REPORTED PT WAS STABLE AT THE TIME OF REPORT AND ON AN INSULIN DRIP. PT WAS ADMITTED TO HOSPITAL WITH BLOOD GLUCOSE OF OVER 60 MMOL/L (1,080 MG/DL). PHYSICIAN ATTEMPTED TO PRIME INFUSION DEVICE WITHOUT A CARTRIDGE OR INFUSION SET IN PLACE. INFUSION DEVICE DISPLAYED OCCLUSION (E4) ERROR DURING EMPTY PRIME. IT WAS UNK HOW LONG ACCESSORIES WERE IN USE PRIOR TO EVENT. INFUSION DEVICE, INFUSION SET, ADAPTER, AND CARTRIDGE WERE REPLACED AND REQUESTED FOR EVAL. ADDITIONAL FOLLOW-UP WAS ATTEMPTED. MOTHER REPORTED PT NO LONGER WAS AT THAT ADDRESS. MOTHER REPORTED SHE WILL GIVE NUMBER TO PT, BUT SHE DOES NOT KNOW WHEN HE WILL CALL BACK. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX® PLUS LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS NA BAV013

    Patients

    Seq Age Sex Outcome Treatment
    1