BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3151437 · Received June 7, 2013

    Report

    Report Number
    2183996-2013-01038
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    June 4, 2013
    Report Date
    July 29, 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
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. RESULT THE DELIVERY ACCURACY AND THE OCCLUSION LIMITS WERE TESTED SUCCESSFULLY AND COMPLY WITH THE PRODUCT SPECIFICATION. ALSO THE ALARM FUNCTIONS WERE TESTED SUCCESSFULLY AND NO MALFUNCTION COULD BE OBSERVED DURING THE TECHNICAL INVESTIGATION. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    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 A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED BEING HOSPITALIZED WITH AN UNEXPECTED ELEVATED BLOOD GLUCOSE LEVEL OF 30.0 MMOL/L (540 MG/DL) AND HI. PATIENT'S NORMAL BLOOD GLUCOSE RANGE WAS NOT PROVIDED. PATIENT STATED SHE GAVE HERSELF A BOLUS OF 6 UNITS OF INSULIN WITH A PEN. PATIENT REPORTED SHE THINKS THE INFUSION DEVICE DID NOT DELIVER THE CORRECT AMOUNT OF INSULIN. PATIENT STATED SHE WENT TO THE HOSPITAL AND WAS ADMITTED. PATIENT REPORTED SHE WAS TREATED WITH INSULIN BY INFUSION. PATIENT STATED SHE WAS HOSPITALIZED FOR 2 DAYS. NO FURTHER INFORMATION IS AVAILABLE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252321 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR Hospitalization| R