BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZE2

    MDR report key: 4251724 · Received November 14, 2014

    Report

    Report Number
    1826988-2014-00417
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 29, 2014
    Report Date
    October 30, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS. THE SECOND BREEZE2 INFORMATION: MODEL 1447A, SERIAL (B)(4), MANUFACTURE DATE 08/24/2013

    Description of Event or Problem · 1

    AMBULANCE PERSONNEL FROM (B)(6) WERE TREATING A PATIENT IN VERY POOR CONDITION. THEY RAN BLOOD TESTS ON HIM USING TWO BREEZE2 METERS AND RECEIVED ONLY READINGS OF E9 AND E10. THE AMBULANCE NURSE GAVE THE PATIENT GLUCOSE, ASSUMING HE WAS HYPOGLYCEMIC. THE NURSE DID NOT REALIZE E10 WAS AN INDICATION THE BLOOD GLUCOSE LEVEL WAS GREATER THAN 83.2MMOL/L. HE WAS UNRESPONSIVE AND TAKEN TO ICU WHERE HE WAS TREATED FOR HYPERGLYCEMIA. THE NURSE DECLINED PRODUCT REPLACEMENT BECAUSE THE METERS CHECKED FINE AND IT WAS LATER CONFIRMED THE PATIENT'S BLOOD GLUCOSE WAS 98.8MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738664 BREEZE2 BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 1447A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R