BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1842754 · Received September 14, 2010

    Report

    Report Number
    2183996-2010-01099
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    April 26, 2010
    Report Date
    April 28, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT REPORTED SHE HAS HAD ELEVATED BLOOD GLUCOSE READINGS FROM 333 MG/DL TO HI ON HER METER WITH NORMAL RANGE BEING AROUND 184-210 MG/DL. SYMPTOMS ARE EXTREME FATIGUE, BLURRED VISION, AND HEADACHE. SHE TREATED HER READINGS BY BOLUSING 25 UNITS OF INSULIN VIA HER INFUSION DEVICE. SHE STATED SHE HAS AN INFECTION AT HER SITE LOCATION WHICH HAS RESULTED IN THE ELEVATED READINGS. SHE SAID THE INFECTION WAS THE RESULT OF HER USING HER HEADSET LONGER THAN RECOMMENDED. SHE STATED THAT ON (B)(6) 2010, SHE WENT TO THE HOSPITAL EMERGENCY ROOM FOR HER ELEVATED READINGS. SHE SAID SHE WAS NOT TREATED AT THE HOSPITAL FOR HER INFECTION OR HER READINGS BUT WAS ADVISED TO CLEAN THE INFECTED AREA WITH ALCOHOL PADS AND APPLY AN ANTIBIOTIC OINTMENT TO IT. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID D INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| O| R INSULIN| INSULIN INFUSION PUMP