BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3061864 · Received April 16, 2013

    Report

    Report Number
    2183996-2013-00683
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    April 12, 2013
    Report Date
    July 24, 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 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

    ON (B)(6) 2013, IT WAS REPORTED THAT ON (B)(6) 2013 THE PATIENT'S INSULIN CARTRIDGE WAS FILED WITH 2.9 UNITS AND THE PATIENT PROGRAMED A BOLUS OF 3.0 UNITS. HE STATED THE INFUSION DEVICE ADMINISTERED THE 3.0 UNITS OF INSULIN, BUT DID NOT DISPLAY W8 (BOLUS CANCELED) AS HE EXPECTED IT TO. HE STATED THAT AFTER THE BOLUS THE DEVICE THAT THERE WERE 2.6 UNITS OF INSULIN LEFT. HE STATED THAT THERE ARE OFTEN AIR BUBBLES IN THE INSULIN CARTRIDGE AND HIS SALES REPRESENTATIVE THINKS THE DEVICE "PULLS" AIR INTO THE CARTRIDGE. THE PATIENT HAS CONSIDERED DISCONTINUING USE OF THE DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163933 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR