BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3010417 · Received March 19, 2013

    Report

    Report Number
    2183996-2013-00400
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 5, 2013
    Report Date
    July 2, 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
    NL
    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. IT IS EXCLUDED THAT THE PUMP PRODUCES CONDENSATION IN THE CARTRIDGE.

    Description of Event or Problem · 1

    PATIENT REPORTED HER BLOOD GLUCOSE WAS 24.0 MMOL/L (432 MG/DL) WHEN SHE WOKE, AND SHE NOTICED CONDENSATION IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE. SHE BELIEVES THERE WAS INSULIN LEAKAGE IN THE SYSTEM. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. THE CARTRIDGE, ADAPTER, AND INFUSION SET WERE DISCARDED AND WILL NOT BE RETURNED. 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
    114069 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 071 YR