BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1081238 · Received July 23, 2008

    Report

    Report Number
    2183996-2008-01080
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 9, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT HE RECEIVED AN E4 ON HIS INFUSION DEVICE WHILE ATTEMPTING TO BOLUS DUE TO ELEVATED BLOOD GLUCOSE OF 288 MG/DL. HIS NORMAL BLOOD GLUCOSE LEVEL IS BELOW 150 MG/DL. HE STATED THAT HE CHANGED THE INFUSION TUBING BUT THE ERROR RECURRED. TO TROUBLESHOOT, THE PATIENT WAS INSTRUCTED TO DISCONNECT FROM HIS INFUSION SITE AND TO PERFORM A BOLUS. HE WAS ABLE TO DO SO WITHOUT ERROR. HE WAS ADVISED TO CHANGE HIS INFUSION SITE. UPON FOLLOW UP ON FIVE DAYS LATER, THE PATIENT STATED THAT HE CHANGED THE INFUSION SITE TO THE RIGHT SIDE OF HIS ABDOMEN AND WAS THEN ABLE TO BOLUS WITHOUT ERROR. HE STATED THAT 3 DAYS LATER, HE INSERTED A NEW INFUSION SITE INTO THE LEFT SIDE OF HIS ABDOMEN AND HIS BLOOD GLUCOSE ELEVATED TO 404 MG/DL AND HE BOLUSED. THE FOLLOWING MORNING HIS BLOOD GLUCOSE MEASURED 408 MG/DL. HE INSERTED AN INFUSION SITE INTO HIS RIGHT SIDE AND HIS BLOOD GLUCOSE IMMEDIATELY DECREASED. HE STATED THAT HE DOES NOT HAVE ANY SCAR TISSUE THAT HE CAN SEE BUT HE USED TO GET "PUMP BUMPS." THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER INFUSION SET INSULIN INFUSION SET FOZ DISETRONIC MEDICAL SYSTEMS NA 598206

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN INFUSION PUMP| INSULIN