BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1132012 · Received August 19, 2008

    Report

    Report Number
    2183996-2008-01257
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    April 1, 2008
    Report Date
    August 4, 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
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT'S MOTHER REPORTED THAT IN APPROX FOUR MONTHS EARLIER, 6 INFUSION SETS FROM TWO SEPARATE BOXES WITH THE SAME LOT AND EXPIRATION DATES "WOULD NOT WORK." THE PATIENT WAS ABLE TO USE AN INFUSION SET FROM ANOTHER LOT NUMBER. THE MOTHER WAS NOT ABLE TO PROVIDE DETAILS. UPON FOLLOW UP WITH THE PATIENT ON ORIGINAL DATE, HE STATED THAT HE EXPERIENCED BLOCKAGES DURING PRIMING (COMPETITOR INFUSION DEVICE) AND ELEVATED BLOOD GLUCOSE OF 300 MG/DL. HIS NORMAL BLOOD GLUCOSE RANGE IS 130-150 MG/DL. HE STATED THAT WHEN HIS BLOOD GLUCOSE WAS ELEVATED, HE WOULD CHANGE THE INFUSION SITE AND EITHER BOLUS THROUGH HIS INFUSION DEVICE OR INJECT INSULIN VIA SYRINGE. HIS WAS NOT EXPERIENCING ELEVATED BLOOD GLUCOSE AT THE TIME OF THE REPORT AND STATED THAT HE'D HAD NO FURTHER ISSUES SINCE BEGINNING USE OF ANOTHER LOT OF INFUSION SETS. HE STATED THAT HE DOES HAVE SCAR TISSUE AND WAS ADVISED BY HIS PHYSICIAN NOT TO USE HIS ABDOMEN AS AN INFUSION SITE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND THE PATIENT WILL RETURN 1 UNUSED INFUSION SET FROM THE LOT AT ISSUE.

    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 163677

    Patients

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