BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT ADAPTER

    MDR report key: 2070432 · Received April 19, 2011

    Report

    Report Number
    2183996-2011-01117
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 20, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED INSULIN LEAKED INTO THE INFUSION DEVICE BECAUSE OF A DAMAGED INFUSION ADAPTER. PATIENT STATED SHE NOTICED THE DAMAGE TO THE ADAPTER. PATIENT REPORTED THE FOUR "FINGERS" ON THE BOTTOM OF THE INFUSION ADAPTER WERE BENT. PATIENT STATED SHE BELIEVED THIS DAMAGE IS WHAT IS CAUSING THE LEAKY INSULIN. PATIENT REPORTED THE INSULIN CARTRIDGE IS NOT CRACKED. PATIENT STATED A LARGE ENOUGH AMOUNT OF INSULIN SPILLED INSIDE THE INFUSION DEVICE THAT COULD BE POURED OUT. PATIENT REPORTED SHE DRIED OUT THE EXCESS MOISTURE WITH A COTTON SWAB, CHANGED TO A NEW INSULIN CARTRIDGE AND CONTINUED TO USE THE INFUSION DEVICE. PATIENT STATED SHE HAD NOT CHANGED THE INFUSION ADAPTER SINCE SHE RECEIVED THE INFUSION DEVICE ABOUT 2.5 YEARS AGO. PATIENT REPORTED SHE RECENTLY READ IN HER USER MANUAL THAT SHE NEEDED TO CHANGE HER INFUSION ADAPTER EVERY 10TH CARTRIDGE CHANGE. PATIENT IS ALSO USING EXPIRED INSULIN CARTRIDGES. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR INSULIN INFUSION PUMP| INSULIN INFUSION SET| INSULIN