BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT ADAPTER

    MDR report key: 3011780 · Received March 19, 2013

    Report

    Report Number
    2183996-2013-00409
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 9, 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

    THE 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. THE PRODUCT MEETS THE SPECIFICATIONS REGARDING THE CUSTOMERS ALLEGATION. THE RECEIVED ADAPTER IS AN ACCU- CHECK SPIRIT COMBO ADAPTER. IT PASSED THE OPTICAL INVESTIGATION AND COMPLIES WITH THE PRODUCT SPECIFICATIONS. ONE USED INFUSION SET WAS RECEIVED FOR EVALUATION. A FREE FLOW AND TIGHTNESS TEST ON THE CONCERNED SAMPLE WAS PERFORMED AND NO IRREGULARITIES WERE FOUND. A VISUAL INSPECTION ON THE RETENTION SAMPLE AND AN ADDITIONAL FREE FLOW AND TIGHTNESS TEST ON ONE RETENTION SAMPLE WERE PERFORMED, AND NO DEVIATIONS WERE FOUND.

    Description of Event or Problem · 1

    PATIENT REPORTED HE CHANGED THE ADAPTER ON (B)(6) 2013 AND EXPERIENCED HYPERGLYCEMIA THAT EVENING (VALUE NOT PROVIDED). HE CHANGED THE INFUSION SET AND DELIVERED INSULIN VIA THE INFUSION DEVICE TO TREAT HYPERGLYCEMIA. ON (B)(6) 2013, HE NOTICED THE ADAPTER CAUSED INSULIN TO LEAK. HE CHANGED THE ADAPTER AGAIN, AND THIS RESOLVED THE ISSUE. HE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE ADAPTER WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113435 ACCU-CHEK ® SPIRIT ADAPTER INSULIN INFUSION PUMP ACCESSORY LZG ROCHE DIABETES CARE AG 00700006865 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 038 YR