BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA

    MDR report key: 10101 · Received August 31, 1993

    Report

    Report Number
    10101
    Event Type
    Injury
    Date Received
    August 31, 1993
    Date of Event
    May 29, 1993
    Report Date
    July 27, 1993
    Manufacturer
    HDI
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    7:25 AM - PATIENT DIAPHORETIC, VOMITING BS. 25 (ULTRA MONITOR) 4 OZ. O.J. GIVEN WITH TWO PACKS OF SUGAR. INSULIN HELD.8:15 AM - VOMITING AGAIN. BS 4 (ULTRA MONITOR) VERFIED X 2 WITH TWO OTHER MONITORS. MD NOTIFIED.8:40 AM - GLUCOGON ADMINISTERED.9:15 - BS 117 (ULTRA MONITOR). HOSPITAL LAB DREW BLOOD. IV STARTED D5W @ 50 CC/HR. CONDITION DETERIORATED.10:00 AM - BS 600 (ULTRA MONITOR). VERFIED WITH 2ND MACHINE.11:45 AM - HOSPITAL LAB RESULTS OF BS 1050 (DRAWN @ 9:15 WHEN ULTRA MACHINE BS DONE TO RECHECK, STILL READING 157, 155. PATIENT TO SENT TO EMERGENCY ROOM, ALMOST UNCONSCIOUS. HOSPITALIZED ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA BLOOD GLUCOSE MONITOR CFR HDI

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R