BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3052087 · Received April 11, 2013

    Report

    Report Number
    2183996-2013-00643
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 21, 2013
    Report Date
    August 27, 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
    AS
    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 OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE ALARM FUNCTIONS OF THE INSULIN PUMP WERE TESTED WITHIN THE ALARM FUNCTION TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEET THE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT BELIEVES HER INFUSION DEVICE IS NOT ADMINISTERING THE FULL BOLUS THAT SHE PROGRAMS. HER BLOOD GLUCOSE LEVEL HAS BEEN ELEVATED TO 30 MMOL/L (540 MG/DL) TO HI. THE PATIENT WAS NOT CONFIDENT IN ACCESSING THE DEVICE'S HISTORY AND DOES NOT REMEMBER THE VOLUME OF HER LAST BOLUS TO BE DELIVERED. THE ISSUE FIRST BEGAN A COUPLE WEEKS PRIOR TO REPORTING. THE PATIENT HAS BEEN UNDER ADDITIONAL STRESS RECENTLY. A CALL HAS BEEN PLACED TO SCHEDULE ADDITIONAL TRAINING WITH THE PATIENT. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156933 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR THYROXIN| PIAX| NEXIUM| RAMRPIL| LIPTOR