BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2833932 · Received November 9, 2012

    Report

    Report Number
    2183996-2012-01720
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    September 30, 2012
    Report Date
    March 13, 2013
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEM INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    SINCE NO MATERIAL HAS BEEN RETURNED FROM THE CUSTOMER AND THE LOT NUMBER IS UNKNOWN, NO INVESTIGATION COULD BE PERFORMED. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT REPORTED THAT THERE WAS INSULIN THAT HAD LEAKED INTO HER INFUSION DEVICE ABOUT ONE MONTH AGO. SHE SAID THE INSULIN WAS LEAKING FROM THE ADAPTER/INSULIN CARTRIDGE AREA AND BACK INTO THE DEVICE. SHE STATED THAT THERE WAS ENOUGH INSULIN IN THE CARTRIDGE COMPARTMENT TO POUR THE INSULIN OUT OF THE DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INSULIN CARTRIDGES AND INFUSION SETS HAVE BEEN DISCARDED. INFUSION DEVICE WAS REPLACED AND WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION. THE INFUSION DEVICE WAS REPLACED AND WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT CARTRIDGE LZG ROCHE INSULIN DELIVERY SYSTEM INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 030 YR RELATED ACCESSORIES| INSULIN| DATES OF THERAPY: UNK| INSULIN INFUSION PUMP