BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1250013 · Received November 14, 2008

    Report

    Report Number
    2183996-2008-01724
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 30, 2008
    Report Date
    October 30, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT WHILE CHANGING THE INSULIN CARTRIDGE, THE PLUNGER BECAME STUCK TO THE PISTON ROD AND A SMALL AMOUNT OF INSULIN SPILLED INTO THE CARTRIDGE COMPARTMENT. THE PATIENT WAS ABLE TO REMOVE THE PLUNGER FROM THE PISTON ROD. HE THEN RECEIVED AN E2 (BATTERY DEPLETED). HE WAS ADVISED TO INSERT A NEW BATTERY. HE STATED THAT HE STORES BATTERIES IN THE FREEZER. HE WAS ADVISED NOT TO STORE BATTERIES IN THE FREEZER. HE STATED THAT HE WOULD ALLOW THE INFUSION DEVICE TO SIT BEFORE INSERTING THE NEW BATTERY. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL 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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR INSULIN INFUSION SET| INSULIN