BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUCHECK

    MDR report key: 1053109 · Received May 16, 2008

    Report

    Report Number
    1053109
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    March 26, 2008
    Report Date
    May 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    ADMISSION PROCESS IN PROGRESS. PATIENT GIVEN BREAKFAST EARLIER - ACCUCHECK DONE PRIOR TO TRANSPORT UPSTAIRS - READ "HI". DOCTOR NOTIFIED - ORDERS FOR 10UNITS REGULAR INSULIN RECEIVED AND GIVEN. SERUM GLUCOSE ORDERED PER PROTOCOL (DRAWN PRIOR TO INSULIN ADMINISTRATION). SERUM GLUCOSE OF 253 RESULTED PER CHART RESULTS APPROXIMATELY 20 MINUTES POST INSULIN ADMINISTRATION. DOCTOR NOTIFIED OF RESULT VARIANCE - ORDERS RECEIVED. ACCUCHECK REPEATED THIRTY-FIVE MINUTES POST INSULIN ADMINISTRATION - RESULT 161. ACCUCHECK EQUIPMENT FROM ANOTHER AREA USED. LAB HERE - ACCUCHECK EQUIPMENT REPLACED AT THAT TIME. UPDATED REPORT GIVEN TO FLOOR RN. PATIENT REMAINED ALERT, ORIENTED, PINK, WARM DRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUCHECK GLUCOSE METER NBW ROCHE DIAGNOSTICS CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR