BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3103129 · Received May 9, 2013

    Report

    Report Number
    2183996-2013-00821
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    February 2, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE ALARM FUNCTION OF THE PUMP WAS TESTED ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS.

    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

    MOTHER REPORTED THE INSULIN DELIVERY OF THE INFUSION DEVICE IS INACCURATE WHEN THE CARTRIDGE VOLUME REACHES 50-80 UNITS. THIS HAS RESULTED IN HYPERGLYCEMIA OF 250-300 MG/DL OVER THE PAST 2-3 MONTHS. PATIENT HAS BEEN ABLE TO SELF-TREAT HYPERGLYCEMIA BY CHANGING THE INFUSION SET AND CARTRIDGE. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203057 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 011 YR