BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1031267 · Received April 18, 2008

    Report

    Report Number
    2183996-2008-00552
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 23, 2008
    Report Date
    April 5, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT HE RECEIVED AN OCCLUSION (E4) ERROR WHILE ATTEMPTING TO BOLUS. HE WAS ABLE TO CLEAR THE ERROR AND HE THEN PROGRAMMED THE REMAINING BOLUS AMOUNT. HE STATED THAT HE CHANGED HIS INFUSION SITE ON THE DAY BEFORE. THE PATIENT CALLED BACK ON ORIGINAL DATE THAT HE HAD EXPERIENCED ELEVATED BLOOD GLUCOSE FOR THE PAST "COUPLE" OF WEEKS DUE TO BENT INFUSION SITE CANNULAS AND OCCLUSION ERRORS. HE REPORTED THAT HE HAD HEART SURGERY IN APPROX TWO MONTHS EARLIER AND WAS NOT USING INFUSION DEVICE THERAPY. HE REPORTED THAT HE EXPERIENCED ELEVATED BLOOD GLUCOSE DURING THAT TIME. HE RECONNECTED TO HIS INFUSION DEVICE ON THE MONTH PRIOR TO ORIGINAL MONTH AND STATED THAT HIS BLOOD GLUCOSE BEGAN TO IMPROVE. HIS BLOOD GLUCOSE THEN BEGAN TO INCREASE TO OVER 600 MG/DL. TO TROUBLESHOOT OCCLUSIONS THE PATIENT WAS INSTRUCTED TO DISCONNECT FROM HIS INFUSION SITE AND HE WAS ABLE TO PERFORM A BOLUS WITHOUT ERROR. HE WAS ADVISED TO CHANGE HIS INFUSION SITE. HE STATED THAT THE CANNULA WAS BENT. HE INSERTED A NEW INFUSION SITE AND BOLUSED WITHOUT ERROR. THE PATIENT WAS EDUCATED ON SCAR TISSUE AND PROPER SITE ROTATION. HE WAS SENT AN INFUSION SITE INSERTION DEVICE. HE STATED HE PLANNED TO SPEAK WITH HIS PHYSICIAN. FURTHER ATTEMPTS TO FOLLOW UP WITH THE PATIENT WERE UNSUCCESSFUL. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R INSULIN INFUSION PUMP| INSULIN