BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2142928 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01891
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE PT REPORTED BEING HOSPITALIZED ON (B)(6) 2011 DUE TO BEING IN A COMA. SPECIFIC BLOOD GLUCOSE VALUES WERE NOT PROVIDED. HIS WIFE DISCONNECTED HIM FROM THE INFUSION DEVICE AND CALLED FOR AN AMBULANCE. THE PT IS ON PERITONEAL DIALYSIS. THE PT HAD ISSUES WITH HIS BLOOD GLUCOSE FOR 2 WEEKS AND HIS BASAL RATE WAS INCREASED FROM 0.7 U/H TO 1.0 U/H PER HIS DIABETES NURSE. THE INFUSION DEVICE WAS LOST DURING THE EVENT AND MAY NOT BE RETURNED 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