BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3103234 · Received May 9, 2013

    Report

    Report Number
    2183996-2013-00826
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 29, 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

    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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. THE FORCE SENSOR IDLE VALUE IS TOO HIGH. THE REASON FOR A SHIFTED FORCE SENSOR IDLE VALUE IS AN EXCESSIVE MECHANICAL FORCE APPLIED EXTERNALLY TO THE PISTON HOLDER IN THE CARTRIDGE COMPARTMENT. THE DEVIATION IN THE FORCE SENSOR IDLE VALUE LED TO A FALSE POSITIVE OCCURRENCE OF THE E4. THE DELIVERY ACCURACY OF THE INSULIN PUMP IS NOT AFFECTED BY THIS FAILURE.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INFUSION DEVICE HAS DISPLAYED SEVERAL E4 OCCLUSION ERRORS OVER THE PAST WEEK AND THE PLUNGER HOLDER ON THE PISTON ROD APPEARS LOOSE. SHE BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS TOO LOW, AND THIS HAS RESULTED IN HYPERGLYCEMIA OF 468 MG/DL. SHE DELIVERED INSULIN VIA PEN AS TREATMENT AND DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202635 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR