BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT ADAPTER

    MDR report key: 1893945 · Received November 3, 2010

    Report

    Report Number
    2183996-2010-02184
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    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
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED HE WAS UNABLE TO PRIME INFUSION DEVICE WITH A NEW CARTRIDGE AND TUBING. PT WAS CONCERNED INSULIN CARTRIDGE MIGHT HAVE LEAKED WHEN HE WAS UNABLE TO COMPLETE PRIME. NO ALERTS OR ERROR MESSAGES WERE RECEIVED ON INFUSION DEVICE. ADAPTER HAD NOT BEEN CHANGED "IN A LONG TIME." ADVISED ON MANUFACTURER RECOMMENDATION FOR ADAPTER. THERE WERE 200 UNITS REMAINING IN INSULIN CARTRIDGE AND PT BELIEVED HE PRIMED APPROXIMATELY 100 UNITS. PT PLACED CARTRIDGE AND TUBING IN BACKUP INFUSION DEVICE, AND IT PRIMED AS INTENDED WITH A NEW ADAPTER. WHEN CARTRIDGE WAS REMOVED FROM PRIMARY INFUSION DEVICE, PT NOTICED CARTRIDGE WAS LEAKING NEAR THE ADAPTER AND LUER LOCK AREA. A SMALL AMOUNT OF INSULIN LEAKED INTO CARTRIDGE CHAMBER, AND PT DRIED CHAMBER WITH A COTTON SWAB. INFUSION DEVICE PISTOL ROD WAS EXTENDING AND RETRACTING AS INTENDED. INFUSION TUBING AND LUER LOCK APPEARED NORMAL. ADAPTER O-RING DID NOT APPEAR DAMAGED AND WAS NOT MISSING. ADAPTER WAS REPLACED AND REQUESTED FOR EVALUATION. FOLLOW-UP WAS COMPLETED. PT REPORTED NEW ADAPTER WAS WORKING AS INTENDED AND EVERYTHING WAS "OK" WITH PRIMARY INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. 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 43 YR INSULIN INFUSION SET| INFUSION DEVICE| INSULIN