BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1063339 · Received June 19, 2008

    Report

    Report Number
    2183996-2008-00911
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 15, 2008
    Report Date
    June 16, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT HE WAS TRAVELING AND HE RECEIVES AN E4 (OCCLUSION) ERROR ON HIS INFUSION DEVICE EACH TIME HE ATTEMPTS TO BOLUS. HE STATED THAT THIS BEGAN ON THE DAY BEFORE, AND IN AN ATTEMPT TO TROUBLESHOOT, HE HAS CHANGED THE BATTERY, INFUSION SITE, AND INFUSION TUBING BUT THE ERROR RECURS. AS A RESULT, HIS BLOOD GLUCOSE ELEVATED TO 20-25 MMOL/L (360-450 MG/DL). HE WAS ABLE TO LOWER HIS BLOOD GLUCOSE TO 6.4 MMOL/L (115 MG/DL) BEFORE BED. HIS NORMAL BLOOD GLUCOSE RANGE IS 6-8 MMOL/L (108-144 MG/DL). TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO DISCONNECT FROM HIS INFUSION DEVICE AND TO BOLUS 5 UNITS OF INSULIN. HE WAS ABLE TO DO SO WITHOUT ERROR. THE PT WAS UNABLE TO COMPLETE TROUBLESHOOTING. UPON FOLLOW UP ON THE DAY AFTER THE ORIGINAL DATE, THE PT STATED THAT HE CHANGED HIS INFUSION SITE AND HAD NO FURTHER ISSUES. HIS BLOOD GLUCOSE RETURNED TO NORMAL. HE STATED THAT THE CANNULA OF THE INFUSION SET WAS BENT DUE TO THE WAY IT HAD BEEN STORED IN HIS SUITCASE. THE PT 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 Required Intervention INSULIN| INSULIN INFUSION PUMP