BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1003004 · Received February 22, 2008

    Report

    Report Number
    2183996-2008-00198
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    February 10, 2008
    Report Date
    February 10, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE BEGAN "FEELING LIKE SHE WAS RUNNING HI" AND HER BLOOD GLUCOSE WAS ELEVATED TO 400 MG/DL. SHE ATTEMPTED TO BOLUS AND RECEIVED AN E4 (OCCLUSION) ERROR. SHE THEN DISCOVERED BLOOD IN HER INFUSION TUBING. SHE WAS INSTRUCTED TO CHANGE HER INFUSION SITE AND SHE WAS THEN ABLE TO BOLUS WITHOUT ERROR. SHE STATED THAT SHE IS A VERY BRITTLE DIABETIC AND HER BLOOD GLUCOSE CAN RANGE ANYWHERE FROM 50-450 MG/DL. SHE STATED THAT SHE HAS NEVER MAINTAINED GOOD CONTROL OF HER BLOOD GLUCOSE READINGS. SHE STATED THAT SHE IS VERY THIN AND HAS A DIFFICULT TIME FINDING INFUSION SITES. SHE STATED THAT THE ONLY AREA THAT WORKS WELL FOR HER IS HER LOWER ABDOMEN. SHE STATED THAT SHE IS VERY ACTIVE AND CAN SOMETIMES FEEL THE CANNULA IN HER BODY. THE PT CALLED BACK ON THE FOLLOWING DAY AND STATED THAT SHE CONTINUED TO RECEIVE ERROR MESSAGES AND HER BLOOD GLUCOSE WAS ELEVATED TO 300 MG/DL. SHE BOLUSED 6 UNITS OF INSULIN. SHE WAS INSTRUCTED TO DISCONNECT FROM HER INFUSION SITE AND TO PRIME THROUGH THE INFUSION TUBING. SHE WAS ABLE TO DO SO WITHOUT ERROR. SHE WAS THEN ADVISED TO CHANGE HER INFUSION SITE. SHE WAS SENT REPLACEMENT INFUSION SETS. UPON FOLLOW UP WITH THE PATIENT ON THREE DAYS LATER, SHE STATED THAT THE ISSUE WAS RESOLVED WITH THE REPLACEMENT INFUSION SETS. THE PT 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 RAPID D INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 211317

    Patients

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