BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLUCOSE SENSOR

    MDR report key: 136092 · Received December 5, 1997

    Report

    Report Number
    2028008-1997-00001
    Event Type
    Death
    Date Received
    December 5, 1997
    Date of Event
    November 12, 1997
    Report Date
    December 4, 1997
    Manufacturer
    VIA MEDICAL CORP.
    Product Code
    LZF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VIA MONITOR THAT HAD BEEN ATTACHED TO AN ARTERIAL LINE WAS DISCONNECTED AND ATTACHED TO THE MID PORT OF A CENTRAL VENOUS CATHETER LINE POST-OPERATIVELY; THE PROXIMAL PORT (WHERE THE VIA SHOULD HAVE BEEN INSTALLED) WAS BEING USED TO DELIVER DEXTROSE TO THE PT. THE VIA MONITOR WAS INDICATING READINGS >600 MG/DL. NURSE ON DUTY BEGAN TREATING FROM THESE VALUES AND GAVE SUBSTANTIAL VOLUME OF INSULIN TO REDUCE THE GLUCOSE LEVEL. SHE CONTINUED THIS TREATMENT FOR APPROX. 6 HRS. A BLOOD SAMPLE WAS TAKEN TO THE LAB AND INDICATED PT BLOOD GLUCOSE LEVEL WAS 17 MG/DL THE NURSE MAKING THE REPORT ( A DIFFERENT NURSE THAT THE ONE WHO HAD USED THE VIA PRODUCT ON THE PT) INDICATED THAT THE DEATH WAS NOT A RESULT OF THE MISTREATMENT BASED UPON THE MISAPPLICATION OF THE VIA MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOSE SENSOR GLUCOSE SENSOR LZF VIA MEDICAL CORP. GLU1A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| R