BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3970654 · Received July 31, 2014

    Report

    Report Number
    1823260-2014-05747
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    February 1, 2014
    Report Date
    July 31, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THE CUSTOMER HAS EXPERIENCED SEVERE HYPOGLYCEMIA FOLLOWING BOLUS DELIVERY. HIS BLOOD GLUCOSE HAS DECREASED TO 40 MG/DL, AND HE HAS LOST CONSCIOUSNESS ON 3-4 OCCASIONS. HIS WIFE HAS TREATED HIM WITH A GLUCAGON INJECTION. THE INFUSION DEVICE WAS EVALUATED, AND NO MALFUNCTION WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446766 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 047 YR Required Intervention