BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3010532 · Received March 19, 2013

    Report

    Report Number
    2183996-2013-00404
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 1, 2013
    Report Date
    May 22, 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 SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. THE DELIVERY ACCURACY OF THE INSULIN PUMP WAS TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND MEETS THE SPECIFICATIONS. THE TECHNICAL INVESTIGATION GAVE NO EVIDENCE THAT THE DEVICE DID CAUSE OR CONTRIBUTE TO THE CONDITION REPORTED BY THE PATIENT.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED HYPERGLYCEMIA OF 200-400 MG/DL FOR 1 WEEK. SHE CHANGED THE ACCESSORIES AND DELIVERED INSULIN VIA THE INFUSION DEVICE, BUT THIS DID NOT LOWER HER BLOOD GLUCOSE. HER INFUSION SITE WAS PAINFUL, AND SHE INITIALLY BELIEVED THIS WAS THE CAUSE. SHE SWITCHED TO A DIFFERENT TYPE OF INFUSION SET, BUT THIS DID NOT RESOLVE THE ISSUE. SHE NOW BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS TOO LOW. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113181 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 020 YR