BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2800075 · Received October 17, 2012

    Report

    Report Number
    2183996-2012-01567
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Report Date
    March 21, 2013
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN A 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.

    Description of Event or Problem · 1

    THE PT REPORTED THAT ON (B)(6) 2012, HE FELT AND HIS BLOOD GLUCOSE MEASURED 370 MG/DL. HE BOLUSED THROUGH THE INFUSION DEVICE AND ONE HOUR LATER HIS BLOOD GLUCOSE MEASURED 270 MG/DL. HE FOUND A LARGE AIR BUBBLE IN THE INSULIN CARTRIDGE AND WHILE TRYING TO REMOVE THE BUBBLE HE HAD ISSUES WITH THE PISTON ROD OF THE INFUSION DEVICE. HE BOLUSED 20 UNITS OF INSULIN THROUGH THE INFUSION DEVICE AND AFTER ONE HOUR HIS BLOOD GLUCOSE MEASURED 280 MG/DL. HE BOLUSED 5 UNITS OF INSULIN AND WAS UNABLE TO LOWER HIS BLOOD GLUCOSE. HE SWITCHED TO A PREVIOUS INFUSION DEVICE AND WAS ABLE TO SUCCESSFULLY BOLUS. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP