BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1031269 · Received April 18, 2008

    Report

    Report Number
    2183996-2008-00562
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    October 8, 2007
    Report Date
    April 8, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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'S MOTHER REPORTED ISSUES WITH BLOOD BACKING UP IN THE INFUSION TUBING OVER THE LAST 6 MONTHS. ON 3 OCCASIONS THE PT EXPERIENCED ELEVATED BLOOD GLUCOSE AS A RESULT. SHE REPORTED THAT ON THE DAY BEFORE, THE PT'S BLOOD GLUCOSE MEASURED 140 MG/DL BEFORE BED, AND SHE WOKE UP THE NEXT MORNING WITH NAUSEA AND VOMITING. HER BLOOD GLUCOSE WAS ELEVATED TO 372 MG/DL AT 6:30 AM AND SHE TESTED POSITIVE FOR MODERATE KETONES. THE PT WAS GIVEN AN INSULIN INJECTION VIA SYRINGE TO LOWER HER BLOOD GLUCOSE. AT THE TIME OF THE REPORT, HER BLOOD GLUCOSE MEASURED 202 MG/DL. THE MOTHER STATED THAT THERE WAS OVER 3 INCHES OF BLOOD BACKED UP IN THE INFUSION TUBING, AND SHE CHANGED THE INFUSION TUBING AND INFUSION SITE. THE PT USES HER BUTTOCK AREA AS AN INFUSION SITE. SITE ROTATION IS LIMITED BECAUSE THE PT WEIGHS 50 LBS. THE INFUSION SITE IS CHANGED EVERY 3-4 DAYS. THE MOTHER WAS ADVISED TO CHANGE THE INFUSION SITE EVERY 2 DAYS. UPON FOLLOW UP ON A WEEK AFTER THE ORIGINAL DATE, THE MOTHER REPORTED THAT ON TWO DAYS AFTER THE ORIGINAL DATE, THE PT TESTED POSITIVE FOR KETONES AND THERE WAS A SMALL HOLE IN THE INFUSION TUBING NEAR THE HEADSET CONNECTION. ON TWO DAYS LATER, THEY WERE NOT ABLE TO PRIME THE INFUSION TUBING. A NEW INFUSION TUBING WAS ATTACHED AND THE PRIME WAS SUCCESSFUL. THERE WERE NO FURTHER ISSUES AFTER THAT DAY. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE ALLEGED PRODUCT WAS NOT RETAINED. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID D INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA UNK

    Patients

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