BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1202727 · Received October 17, 2008

    Report

    Report Number
    2183996-2008-01599
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 5, 2008
    Report Date
    October 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
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED HE CHANGED THE INSULIN CARTRIDGE OF HIS INFUSION DEVICE AND HIS INFUSION SET. HE SAID WHEN HE TRIED TO PRIME THE INFUSION SET, IT WOULD NOT PRIME AND HIS INFUSION DEVICE GAVE AN E6 (MECHANICAL ERROR) ALARM. HE STATED HE HAD CHANGED THE DEVICE BATTERY ONE DAY PRIOR, SO HE CHANGED THE INFUSION SET AGAIN AND WAS ABLE TO SUCCESSFULLY PRIME WITH NO ALARMS GIVEN. HE STATED THAT DURING THIS TIME, HIS BLOOD GLUCOSE READING ELEVATED TO 316 MG/DL WHICH HE CORRECTED BY BOLUSING 2 UNITS OF INSULIN. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION. THE FOLLOWING MONTH, NOTIFICATION WAS RECEIVED THAT THE PATIENT HAD RETURNED 2 LOTS OF INFUSION SETS FOR EVALUATION. THE INITIAL LOT WAS REPORTED ON 2183996-2008-01458.

    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 114765

    Patients

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