BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1041131 · Received May 8, 2008

    Report

    Report Number
    2183996-2008-00644
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    January 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 04/29/2008, THE PATIENT REPORTED THAT INSULIN IS LEAKING FROM HER INFUSION SITE NEAR THE INFUSION TUBING CONNECTION DURING BOLUSES. SHE STATED THAT SHE NOTICED THIS SEVERAL MONTHS AGO BUT HER BLOOD GLUCOSE HAS "BEEN OUT OF CONTROL" FOR APPROXIMATELY 1 YEAR. SHE STATED THAT THE INSULIN SEEMS TO BE "BACKING UP" AND SHE CAN SMELL INSULIN AND HER CLOTHING BECOMES WET. AS A RESULT OF THIS, HER BLOOD GLUCOSE HAVE ELEVATED TO OVER 600 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS 80-160 MG/DL. HER MOST RECENT BLOOD GLUCOSE READING WAS 212 MG/DL AND SHE BOLUSED 10 UNITS OF INSULIN. SHE STATED THAT SHE CHANGES HER INFUSION SITE EVERY 4 DAYS. SHE WAS ADVISED TO CHANGE THE INFUSION SITE EVERY 3 DAYS. SHE STATED THAT SHE ROTATES HER INFUSION SITES IN A 3 INCH AREA ON EACH SIDE OF HER BELLY BUTTON. SHE STATED, SHE HAS USED THIS AREA FOR 15 YEARS. SHE WAS EDUCATED ON PROPER INFUSION SITE ROTATION AND SCAR TISSUE. SHE STATED THAT SHE HAS SCAR TISSUE ON THE RIGHT SIDE OF HER ABDOMEN AND SHE DOES INSERT INFUSION SITES NEAR THAT AREA. SHE WAS ADVISED TO STAY 2 INCHES AWAY FROM SCAR TISSUE AND TO TRY USING NEW INFUSION SITE AREAS. UPON FOLLOW UP THE NEXT MONTH, THE PATIENT STATED THAT SHE BEGAN USING HER UPPER ABDOMEN AS AN INFUSION SITE AND SHE HAS NOT EXPERIENCED ANY FURTHER INSULIN LEAKAGE AND HER BLOOD GLUCOSE LEVELS HAVE IMPROVED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PATIENT WILL RETURN HER HEADSET 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 574503

    Patients

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