BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1832084 · Received September 8, 2010

    Report

    Report Number
    2183996-2010-01858
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 21, 2010
    Report Date
    August 23, 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 EXPERIENCING UNEXPLAINED ELEVATED BLOOD GLUCOSE LEVELS FOR SEVERAL WEEKS UP TO 530 MG/DL; TOOK CORRECTION VIA THE INFUSION DEVICE. PATIENT REPORTED SHE SWITCHED TO HER BACKUP INFUSION DEVICE ON (B)(6)2010 AND HER BLOOD GLUCOSE LEVEL RETURNED TO NORMAL. PATIENT REPORTED SHE STARTED ON HER PRIMARY INFUSION DEVICE ON (B)(6)2010 AND HER BLOOD GLUCOSE LEVEL AT 10:30 AM WAS 189 MG/DL; ADMINISTERED 1.0 UNIT OF INSULIN VIA THE INFUSION DEVICE, AT 1:00 PM HER BLOOD GLUCOSE WAS 119 MG/DL; SHE ATE AND ADMINISTERED 2.0 UNITS OF INSULIN VIA THE INFUSION DEVICE, AT 4:00 PM HER BLOOD GLUCOSE WAS 112 MG/DL; SHE ATE AND ADMINISTERED 3.0 UNITS OF INSULIN VIA THE INFUSION DEVICE, AT 6:00 PM, HER BLOOD GLUCOSE WAS 410 MG/DL; SHE ADMINISTERED 5.0 UNITS OF INSULIN VIA THE INFUSION DEVICE AND AT 7:00 PM, THE PATIENT ADMINISTERED 5.0 UNITS OF INSULIN VIA THE INFUSION DEVICE. PATIENT REPORTED SHE BEGAN TO FEEL VERY SICK AND AT 8:30 PM, HER BLOOD GLUCOSE READING WAS 465 MG/DL; PATIENT SWITCHED FROM THE PRIMARY INFUSION DEVICE TO HER BACKUP INFUSION DEVICE. PATIENT STATED AFTER SWITCHING TO HER BACKUP INFUSION DEVICE HER BLOOD GLUCOSE RETURNED TO NORMAL. PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 100-120 MG/DL. PATIENT REPORTED SHE THINKS THE INFUSION DEVICE WAS NOT DELIVERING THE CORRECT AMOUNT OF INSULIN. NO FURTHER INFORMATION IS AVAILABLE. 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 INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention INSULIN| INSULIN INFUSION SET