BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2861516 · Received November 28, 2012

    Report

    Report Number
    2183996-2012-01838
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 22, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE UNITED STATES. INFORMATION CONTAINED IN 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

    ON (B)(6) 2012, IT WAS REPORTED THAT WHEN THERE IS 100 UNITS OF INSULIN LEFT IN THE PATIENT'S INSULIN CARTRIDGE THE INFUSION DEVICE DOES NOT DELIVER INSULIN. THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 25-29 MMOL/L (450-522 MG/DL). AFTER CHANGING THE INSULIN CARTRIDGE, THE PATIENT'S BLOOD GLUCOSE LEVEL WENT DOWN. THE INCIDENT FIRST OCCURRED ON (B)(6) 2012. THE SECOND TIME THIS HAPPENED WAS ON (B)(6) 2012 AND THE PATIENT WENT TO THE HOSPITAL. WHEN HE ARRIVED AT THE HOSPITAL HIS BLOOD GLUCOSE LEVEL HAD ALREADY RETURNED TO NORMAL AND HE RETURNED HOME. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS TESTED AT THE HOSPITAL AND WAS 18 MMOL/L (324 MD/DL) WHICH IS ALSO WHAT THE PATIENT'S BLOOD GLUCOSE MONITOR READ. THE PATIENT STATES THAT THE DEVICE FAILS TO DELIVER INSULIN WHEN THE PISTON ROD REACHES 100 UNITS OF INSULIN IN THE CARTRIDGE AND DOES NOT DISPLAY AND ERROR CODE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR INSULIN INFUSION PUMP| RELATED ACCESSORIES| INSULIN