BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1202505 · Received October 8, 2008

    Report

    Report Number
    2183996-2008-01556
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 30, 2008
    Report Date
    September 30, 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

    IN 2008, THE PATIENT STATED THAT HE HAD NOT PROPERLY INSERTED HIS INSULIN CARTRIDGE INTO THE INFUSION DEVICE AND WHEN HE REMOVED THE CARTRIDGE, THE PLUNGER BECAME STUCK TO THE PISTON ROD AND 315 UNITS OF INSULIN SPILLED INTO THE CARTRIDGE COMPARTMENT. HE WAS EDUCATED ON HOW TO PROPERLY REMOVE THE INSULIN CARTRIDGE FROM THE INFUSION DEVICE. THE PATIENT DOES NOT HAVE A BACKUP INFUSION DEVICE AND WAS OUT OF TOWN. HE WAS ADVISED TO CONTACT HIS PHYSICIAN FOR INSTRUCTIONS ON INSULIN THERAPY. HE STATED THAT HE WILL DRY THE INFUSION DEVICE AND CONTINUE USING IT UNTIL THE REPLACEMENT DEVICE ARRIVES. 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 EVAL.

    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 35 YR INSULIN INFUSION SET| INSULIN