BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2861535 · Received November 28, 2012

    Report

    Report Number
    2183996-2012-01801
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 16, 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
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED FOR EVALUATION ON (B)(4) 2012. THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. THE VIBRA SHAFT IS BENT DUE TO A MECHANICAL INFLUENCE. BECAUSE OF THIS, THE VIBRATOR DOES NOT PROVIDE FEEDBACK. E4 OCCLUSION ERRORS WERE FOUND IN THE HISTORY, AND THE OCCLUSION LIMITS WERE TESTED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT 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) 2012, IT WAS REPORTED THAT THE PATIENT'S INFUSION DEVICE DISPLAYED E8 (POWER INTERRUPT), E7 (ELECTRIC ERROR), AND E4 ( OCCLUSION ERROR). THE INFUSION DEVICE'S VIBRATOR IS NOT FUNCTIONING. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. 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
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006863 NA

    Patients

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