BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2232513 · Received August 25, 2011

    Report

    Report Number
    2183996-2011-02323
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE U.S. 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

    DIABETIC COUNSELOR REPORTED THAT PT WAS HOSPITALIZED ON (B)(6) 2011 WITH DIABETIC KETOACIDOSIS, AND PT WAS TRANSPORTED TO THE HOSP BY AMBULANCE. DIABETIC COUNSELOR REPORTED THE BASAL RATES WERE SET ¿VERY LOW¿ ON THE INFUSION DEVICE AT 8 I.E. PER DAY, THERE WAS A LARGE AIR BUBBLE IN THE INSULIN CARTRIDGE OR THE INFUSION TUBE, THE DATE WAS PROGRAMMED WRONG, THERE WAS LIQUID IN THE CARTRIDGE COMPARTMENT OF THE INFUSION DEVICE, AND ONLY BASAL RATES, NOT BOLUSES, WERE DELIVERED THROUGH THE INFUSION DEVICE. THE PT WAS NOT APPROACHABLE AND NO FURTHER INFO WAS AVAILABLE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL.

    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 Hospitalization| R INSULIN INFUSION SET| INSULIN