BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3052164 · Received April 11, 2013

    Report

    Report Number
    2183996-2013-00647
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    April 4, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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.

    Additional Manufacturer Narrative · 1

    THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT ON (B)(6) 2013 THE PATIENT'S BLOOD GLUCOSE LEVEL WAS DOWN TO 40-45 MG/DL. THE PATIENT ATE PIECES OF GLUCOSE, BUT THE BLOOD GLUCOSE LEVEL DID NOT RETURN TO NORMAL. AROUND 8:00-8:30PM SHE FELT SICK, DIZZY, NAUSEOUS, AND SLOW TO REACT. HER HUSBAND CALLED FOR AN AMBULANCE/DOCTOR ON CALL. THE PATIENT'S DOCTOR MEASURED HER BLOOD GLUCOSE LEVEL AND IT WAS 41 MG/DL. HE GAVE HER GLUCOSE LIQUID ORALLY AND AN INFUSION OF GLUCOSE. THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE SHE WAS MONITORED IN THE EMERGENCY ROOM FOR FOUR HOURS. THE PATIENT AND HER DOCTOR THINK THE INFUSION DEVICE DELIVERED TOO MUCH INSULIN. INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154852 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 064 YR Hospitalization| R NOVORAPID