BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 3010413 · Received March 19, 2013

    Report

    Report Number
    2183996-2013-00402
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 7, 2013
    Report Date
    May 10, 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 COMPLAINT CANNOT BE VERIFIED. THE MATERIAL MEETS PRODUCT SPECIFICATIONS. THE TWO USED AND FOURTEEN UNUSED CARTRIDGES WERE VISUALLY, LEAK AND GLIDE FORCE TESTED. THE CARTRIDGES 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 TWO USED RETURNED TRANSFER SETS WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. BOTH TRANSFER SETS WERE OCCLUDED WITH INSULIN BEHIND THE CONNECTOR NEEDLE. THE MANUFACTURER TESTS ALL PRODUCTS DURING PRODUCTION FOR LEAK AND FLOW; THEREFORE, THERE IS NO INDICATION THAT A NONSPECIFIC PRODUCT WAS DELIVERED TO THE CUSTOMER. THE ADAPTER PASSED THE OPTICAL INSPECTION.

    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.

    Description of Event or Problem · 1

    PATIENT REPORTED THE CARTRIDGES HAVE LEAKED INSULIN NEAR THE ADAPTER. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE CARTRIDGES WERE REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114620 ACCU-CHEK SPIRIT CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ROCHE DIABETES CARE AG 00700006871 32392262

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR