BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2190611 · Received July 27, 2011

    Report

    Report Number
    2183996-2011-02105
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 18, 2011
    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
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED THAT INSULIN SPILLED IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE ON (B)(6) 2011 DUE TO MISHANDLING OF THE CARTRIDGE. PT'S BLOOD GLUCOSE WAS 420 MG/DL WHEN SHE WOKE UP ON (B)(6) 2011 AT 3:00 AM, AND SHE DELIVERED A CORRECTION BOLUS VIA THE INFUSION DEVICE. BLOOD GLUCOSE WAS 540 MG/DL AT 9:00 A.M., AND SHE DELIVERED A CORRECTION VIA SYRINGE. PT BELIEVES THE INFUSION DEVICE DELIVERS TOO LITTLE INSULIN PT DID NOT HAVE AN INFECTION BUT DID START NEW MEDICATION. SHE HAD A CARDIAC PACEMAKER INSERTED ON (B)(6) 2011, AND THE INFUSION DEVICE WAS EXPOSED TO X-RAY DURING A SCAN OF HER RIGHT ARM. INFUSION DEVICE WAS NOT EXPOSED TO WATER. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR INSULIN INFUSION SET| INSULIN