BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2896337 · Received December 5, 2012

    Report

    Report Number
    2183996-2012-01906
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 30, 2012
    Report Date
    March 11, 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
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT RETURNED ON (B)(4) 2012. THE ALARM FUNCTIONS OF THE INSULIN PUMP WAS TESTED WITHIN THE ALARM FUNCTION TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE 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 THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PT'S INFUSION DEVICE DOES NOT DISPLAY W2 (LOW CARTRIDGE) BEFORE IT DISPLAYS E1 (CARTRIDGE EMPTY). THE PT WAS LEFT WITH NO INSULIN BECAUSE SHE DID NOT REALIZE SHE WAS RUNNING LOW. CHECKING THE HISTORY IN THE DEVICE SHOWS E1 WAS DISPLAYED ON (B)(6) 2012 WITHOUT FIRST DISPLAYING W2. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT 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 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 32 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP