BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3011783 · Received March 19, 2013

    Report

    Report Number
    2183996-2013-00408
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 5, 2013
    Report Date
    September 25, 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
    BR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    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.

    Description of Event or Problem · 1

    MOTHER REPORTED THERE WAS INSULIN LEAKAGE IN THE INFUSION DEVICE SYSTEM. THE PATIENT DID NOT EXPERIENCE ANY PHYSIOLOGICAL EFFECTS OR REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE ALLEGED PRODUCTS WERE REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113566 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1