BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 3052075 · Received April 11, 2013

    Report

    Report Number
    2183996-2013-00642
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 28, 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
    AR
    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 AND THE OCCLUSION LIMITS WERE TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSIS TEST AND MEET THE SPECIFICATION. ALL ALARM FUNCTIONS WERE TESTED SUCCESSFUL 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL ON (B)(6) 2013 WITH SYMPTOMS OF HYPERGLYCEMIA; HIS BLOOD GLUCOSE LEVEL WAS 145 MG/DL. HE EXPERIENCED CHEST AND MUSCLE PAIN, VOMITING, AND DIARRHEA. HIS DOCTOR INITIALLY ADMINISTERED 8 UNITS OF INSULIN AND THEN AN ADDITIONAL 6 UNITS OF INSULIN AT A LATER TIME. THE PATIENT WAS IN THE HOSPITAL FOR 6-7 HOURS. WHILE AT THE HOSPITAL IT WAS NOTICED THAT THE CANNULA OF THE PATIENT'S INFUSION SET WAS BENT AND THE INFUSION DEVICE DID NOT DISPLAY ANY ERROR OR ALERT MESSAGE. THE USED INFUSION SET HAD BEEN DISCARDED BY THE PATIENT. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156862 ACCU-CHEK SPIRIT INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 041 YR Hospitalization| R ENALAPRIL 2.5 MG (1 PER DAY)