BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1935351 · Received December 16, 2010

    Report

    Report Number
    2183996-2010-02632
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 10, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED SHE DID NOT RECEIVE AN E4 (OCCLUSION) ERROR MESSAGE. PATIENT REPORTED THE INFUSION DEVICE DISPLAYED AN A5 (PUMP TIMER) ALERT ON (B)(6) 2010 AT 11:00 AM. PATIENT STATED IN THE EVENING HER BLOOD GLUCOSE LEVEL WAS 420 MG/DL. PATIENT REPORTED SHE REMOVED THE INFUSION NEEDLE AND GAVE A BOLUS, BUT NO INSULIN FLOWED OUT OF THE END OF THE NEEDLE. PATIENT STATED SHE FIRST TOOK A CORRECTION VIA THE PEN AND THEN CHANGED THE INFUSION SET AND TOOK ANOTHER CORRECTION VIA THE INFUSION DEVICE. PATIENT REPORTED HER BLOOD GLUCOSE LEVEL WAS THEN OKAY. PATIENT STATED ON (B)(6) 2010, HER BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 300 MG/DL AT 11:00 AM AND SHE TOOK A CORRECTION VIA THE PEN. PATIENT REPORTED SHE REMOVED THE NEEDLE AND GAVE A BOLUS, BUT NO INSULIN FLOWED OUT OF THE NEEDLE. PATIENT STATED SHE THEN CHANGED THE INFUSION SET. PATIENT REPORTED WHEN SHE WENT TO BED THAT NIGHT HER BLOOD GLUCOSE LEVEL WAS 160 MG/DL WHICH WAS NORMAL FOR HER. PATIENT STATED ON (B)(6) 2010 AT 6:45 AM HER BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 400 MG/DL, SHE REMOVED THE NEEDLE AND GAVE A BOLUS, AND THEN AFTER 5.0 UNITS OF INSULIN, A SMALL QUANTITY OF INSULIN FLOWED OUT OF THE NEEDLE. PATIENT REPORTED SHE CHANGED THE INFUSION SET AND TOOK A CORRECTION VIA THE PEN. PATIENT'S NORMAL BLOOD GLUCOSE LEVEL IS 130-150 MG/DL. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention INSULIN| INSULIN INFUSION SET