BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1030018 · Received April 14, 2008

    Report

    Report Number
    2183996-2008-00527
    Event Type
    Injury
    Date Received
    April 14, 2008
    Date of Event
    March 30, 2008
    Report Date
    April 3, 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
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED THAT ALTHOUGH HE TWISTS HIS INSULIN INFUSION SET INTO THE ADAPTER AS USUAL, THE INFUSION SET HAS DISCONNECTED FROM THE ADAPTER 2 TIMES. HE SAID IN 2008, HE BEGAN HAVING ELEVATED BLOOD GLUCOSE READINGS AND ONE DAY PRIOR, HE DISCOVERED THE INFUSION SET HAD DISCONNECTED FROM THE ADAPTER AFTER HE HAD A BLOOD GLUCOSE READING OF 407 MG/DL. HE STATED HIS SYMPTOM WAS THIRST AND HE CORRECTED HIS READING TO HIS NORMAL RANGE OF AROUND 150 MG/DL BY BOLUSING 4 UNITS OF INSULIN. THE PT STATED THE INFUSION SET AGAIN DISCONNECTED FROM THE ADAPTER THE FOLLOWING MONTH. HE STATED HIS BLOOD GLUCOSE WAS NOT AFFECTED IN THAT INCIDENT HE SAID BOTH OF THE INFUSION SETS CAME FROM THE SAME BOX. ON F/U, THE PT STATED HE REC'D THE REPLACEMENT PROD AND IS HAVING NO FURTHER ISSUES. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PROD WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    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 034316

    Patients

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