BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 2110214 · Received May 20, 2011

    Report

    Report Number
    2183996-2011-01446
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 26, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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) 2011, PATIENT REPORTED HE HAD AN INFUSION SET "PLUG UP" ON HIM AND HE DID NOT HAVE TIME TO TEST HIS BLOOD GLUCOSE, SO HE ENDED UP FACING AN ELEVATED BLOOD GLUCOSE READING. PT STATED THE INCIDENT OCCURRED ON (B)(6) 2011. PT REPORTED HE GOT REALLY BUSY AND DID NOT TAKE CARE OF HIMSELF. PT STATED, THE INFUSION HEADSET WAS DUE TO BE CHANGED AND HE SHOULD HAVE STOPPED WHAT HE WAS DOING AND TEST, BUT HE DID NOT. PT REPORTED HIS BLOOD GLUCOSE READING WAS 398 MG/DL. PT'S TARGET BLOOD GLUCOSE RANGE IS 120-125 MG/DL OR LESS. PT STATED, HE DID NOT RECEIVE ANY ERROR MESSAGE ON THE INFUSION DEVICE. PT REPORTED WHEN HE DID CHANGE THE INFUSION SET PIGTAIL, HE NOTICED INSULIN WAS SOAKING THE AREA AROUND THE INFUSION SET NEEDLE. PT STATED, HE CHANGED THE PIGTAIL, BOLUSED AND THEN TOOK AN INJECTION OF INSULIN. PT REPORTED HIS BLOOD GLUCOSE LOWERED INTO THE TARGET RANGE. PT DISCARDED THE ALLEGED INFUSION SET. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 61 YR INSULIN| INSULIN INFUSION PUMP