BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1243182 · Received November 7, 2008

    Report

    Report Number
    2183996-2008-01676
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2008, THE PATIENT REPORTED THAT WHILE CHANGING THE INSULIN CARTRIDGE E10 (CARTRIDGE) ERROR WAS DISPLAYED ON HER INFUSION DEVICE. SHE REMOVED THE INSULIN CARTRIDGE AND THE PLUNGER BECAME STUCK ON THE PISTON ROD OF THE INFUSION DEVICE, AND THE ENTIRE CONTENTS OF THE CARTRIDGE SPILLED INTO THE CARTRIDGE COMPARTMENT. SHE WAS EDUCATED ON THE PROPER PROCEDURE FOR REMOVING THE INSULIN CARTRIDGE FROM THE INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR INSULIN INFUSION SET| INSULIN