BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1726586 · Received June 14, 2010

    Report

    Report Number
    2183996-2010-01247
    Event Type
    Injury
    Date Received
    June 14, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 15, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD AND RESULTS - NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B) (6) 2010, PATIENT'S DAUGHTER REPORTED THAT THE PATIENT EXPERIENCED AN ELEVATED BLOOD GLUCOSE. PATIENT'S DAUGHTER STATED ON (B) (6) 2010, PATIENT TOOK A SHOWER AND RECONNECTED TO HER INFUSION SITE. DAUGHTER REPORTED THE PATIENT BECAME SICK AND NOTICED HER BLOOD GLUCOSE WAS 500 MG/DL. DAUGHTER STATED THEY REMOVED THE INFUSION SITE AND NOTICED THE NEEDLE WAS BENT. NO OCCLUSION ALERT DISPLAYED ON THE INFUSION DEVICE. PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 140-200 MG/DL. DAUGHTER REPORTED THE PATIENT WAS HOSPITALIZED DUE TO THE ELEVATED BLOOD GLUCOSE. PATIENT HAD ALREADY SWITCHED TO HER BACKUP INFUSION DEVICE. DAUGHTER STATED THE HOSPITAL STAFF INJECTED INSULIN WHILE THE PATIENT WAS CONNECTED TO HER BACKUP INFUSION DEVICE AND HER BLOOD GLUCOSE DROPPED TO 25 MG/DL. DAUGHTER REPORTED PATIENT'S BLOOD GLUCOSE IS NOW UNDER CONTROL, BUT SHE REMAINS HOSPITALIZED. NO PRODUCT RETURN WAS REQUESTED.

    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 72 YR Hospitalization| O| R INSULIN ((B) (6))| INSULIN INFUSION PUMP ((B) (6))