BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1063324 · Received June 19, 2008

    Report

    Report Number
    2183996-2008-00900
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 9, 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
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON 06/09/2008, THE PT REPORTED THAT 5 DAYS AGO, HIS BLOOD GLUCOSE ELEVATED TO 479 MG/DL AND HE FELT DIZZY AND NAUSEATED. HIS PHYSICIAN ADVISED HIM TO CHANGE HIS INFUSION SITE AND HE FOUND THAT THE CANNULA WAS SEPARATED FROM THE HOUSING. THE INFUSION SITE HAD BEEN IN USE FOR 2 DAYS. HE INSERTED A NEW INFUSION SITE AND ADMINISTERED 2 INJECTIONS OF INSULIN TOTALING 80 UNITS. WITHIN 7 HOURS HIS BLOOD GLUCOSE HAD RETURNED TO NORMAL (80-120 MG/DL). HE REPORTED THAT AT 11:30 AM HIS BLOOD GLUCOSE ELEVATED TO 207 MG/DL AND HE BOLUSED TO LOWER HIS READINGS TO 163 MG/DL. UPON FOLLOW UP ON A WEEK AFTER THE ORIGINAL DATE, THE PT REPORTED THAT HIS BLOOD GLUCOSE HAD RETURNED TO NORMAL AND HE HAD NO FURTHER CONCERNS. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PT DID NOT RETAIN THE ALLEGED INFUSION SITE AND DID NOT HAVE THE LOT/EXPIRATION INFO. NO PRODUCT WILL BE RETURNED FOR EVAL.

    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 Required Intervention INSULIN| INSULIN INFUSION PUMP