BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2943299 · Received January 21, 2013

    Report

    Report Number
    2183996-2013-00029
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    December 13, 2012
    Report Date
    March 28, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS 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 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. THE ADAPTER PASSED THE OPTICAL INSPECTION. THE RECEIVED USED CARTRIDGE WAS VISUALLY, LEAK AND GLIDE FORCE TESTED. CARTRIDGE PASSED THE VISUAL TEST AND THE LEAKAGE TEST AT DIFFERENT POSITIONS OF THE PLUNGER ROD. THE GLIDE FORCE MEASURED IS IN ACCORDANCE WITH PRODUCT SPECIFICATIONS. THE USED RETURNED INFUSION SET WAS VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. AN OCCLUSION WITH INSULIN WAS FOUND BEHIND THE CONNECTOR NEEDLE OF THE TRANSFER SET. THE MANUFACTURER TESTS THE PRODUCTS DURING PRODUCTION FOR LEAKS AND FLOW, SO IT IS ASSUMED THAT THE PRODUCT WAS WITHIN THE SPECIFICATIONS AT DELIVERY.

    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

    PATIENT HAS EXPERIENCED HYPERGLYCEMIA AS HIGH AS 370 MG/DL OVER THE PAST 3 WEEKS. HE CHANGED THE CARTRIDGE AND INFUSION SET AND DELIVERED INSULIN VIA THE INFUSION DEVICE, BUT THIS WAS NOT SUCCESSFUL IN LOWERING BLOOD GLUCOSE. HE THEN USED AN INSULIN PEN. PATIENT BELIEVES THE INSULIN DELIVERY OF THE INFUSION DEVICE IS INACCURATE. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. HE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28708 ACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN