BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 2991999 · Received March 7, 2013

    Report

    Report Number
    2183996-2013-00330
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 26, 2013
    Report Date
    June 21, 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
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED. THE PRODUCT MEETS THE SPECIFICATIONS REGARDING THE CUSTOMER'S ALLEGATION. 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.

    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.

    Description of Event or Problem · 1

    FATHER REPORTED THE PATIENT HAS EXPERIENCED CONSISTENT HYPOGLYCEMIA, AND HE BELIEVES THE INFUSION DEVICE MIGHT BE OVER-DELIVERING INSULIN. PATIENT'S BLOOD GLUCOSE HAS BEEN BETWEEN 3.0-4.7 MMOL/L (54-84.6 MG/DL), AND HIS FATHER AND A TEACHER'S AIDE OPERATE THE INFUSION DEVICE. PATIENT HAS EXPERIENCED HYPOGLYCEMIC SYMPTOMS OF VOMITING AND LETHARGY. FATHER CONSULTED WITH DOCTOR ON (B)(6) 2013 AT 12:30 P.M., AND PATIENT WAS GIVEN A SUGARY DRINK TO INCREASE HIS BLOOD GLUCOSE. DOCTOR WAS CONSULTED AGAIN ON (B)(6) 2013 AT 9:00 A.M., AND NO CAUSE WAS ESTABLISHED FOR HYPOGLYCEMIA. PATIENT MET WITH A DIABETES EDUCATOR AT 9:30 A.M., AND THE INFUSION DEVICE SETTINGS WERE REVIEWED. THE BASAL RATES WERE DECREASED, AND THE DIABETES EDUCATOR QUESTIONED THE INSULIN DELIVERY OF THE INFUSION DEVICE. PATIENT CONTINUED TO USE THE INFUSION DEVICE AND WAS BEING MONITORED BY HIS FATHER AND TEACHER'S AIDE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97397 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 005 YR Required Intervention NOVO RAPID INSULIN