BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1071406 · Received July 7, 2008

    Report

    Report Number
    2183996-2008-00988
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 24, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED RECEIVING RECURRING 04 (OCCLUSION) MESSAGES ON HER INSULIN INFUSION DEVICE. TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO DISCONNECT FROM HER INFUSION HEADSET AND PRIME THE TUBING WHICH SHE DID WITHOUT ERROR. SHE STATED, SHE HAD CHANGED HER HEADSET THE "NIGHT BEFORE LAST". ON F/U WITH THE PT ON THREE DAYS LATER, SHE STATED THAT OVER A 36 HR PERIOD, SHE HAD TO CHANGE HER INFUSION SET TUBING 5 TIMES AND HER HEADSET 2 TIMES DUE TO OCCLUSION ERRORS. SHE SAID, THE OCCLUSIONS OCCURRED DURING PRIMES AND DURING USE, USUALLY WHILE SHE WAS SLEEPING AT NIGHT. SHE STATED SHE HAD ELEVATED BLOOD GLUCOSE READING FROM 300 MG/DL TO "HI". SHE STATED, SHE TREATED HER READINGS BY BOLUSING HER HEADSET AND TUBING. SHE SAID THE ERRORS HAVE STOPPED AND HER READINGS ARE SLOWLY COMING DOWN WITH HER LAST READING BEING 224 MG/DL. THE PT STATED, SHE IS UNSURE IF HER READINGS ARE DUE TO THE ERRORS OR TO THE INFECTIONS SHE CURRENTLY HAS. SHE SAID SHE HAS STARTED SOME NEW MEDICATIONS. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PROD WAS REPLACED AND 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 570375

    Patients

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