BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT ADAPTER

    MDR report key: 2024062 · Received March 11, 2011

    Report

    Report Number
    2183996-2011-00518
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    January 15, 2011
    Report Date
    February 15, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THAT INSULIN LEAKED AROUND THE ADAPTER APPROXIMATELY 1 MONTH AGO. BLOOD GLUCOSE WAS ELEVATED (READING UNK), AND PT STARTED TO "CHANGE EVERYTHING." SHE NOTICED THE ADAPTER WAS BROKEN AND INSULIN WAS LEAKING. PT CHANGED THE ADAPTER AND BLOOD GLUCOSE DECREASED. PT WAS ADVISED ON THE MANUFACTURER RECOMMENDATION FOR THE ADAPTER. TARGET BLOOD GLUCOSE IS 80-120 MG/DL. NO PRODUCT WAS REQUESTED FOR EVAL. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 60 YR INSULIN INFUSION SET| INSULIN| INSULIN INFUSION DEVICE