BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK INFORM METER

    MDR report key: 1222404 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08173
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 8, 2008
    Report Date
    April 27, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING AN EXTREMELY LOW RESULT THAT WAS TOO LOW TO REGISTER WHICH COULD HAVE BEEN AN ERROR MESSAGE, ON A PT USING THE INFORM SYSTEM AFTER THE PT WAS FOUND ON THE FLOOR. REPORTER STATED THE PT WAS GIVEN AN IV, BLOOD WAS DRAWN, AND OTHER TESTS TOO LOW TO REGISTER WERE OBTAINED ON THE SAME SYSTEM. REPORTER STATED THE PT WAS TREATED WITH IV FLUIDS OF DEXTROSE 5% AND WITH HALF THE NORMAL SALINE. REPORTER STATED THAT 35 MINUTES LATER, THE LAB REPORTED A RESULT OF 1284 MG/DL ON THEIR SYSTEM. REPORTER STATED THE PT WAS STARTED ON AN INSULIN DRIP AND THE IV FLUID WAS CHANGED TO NORMAL SALINE. REPORTER STATED THAT ANOTHER UNKNOWN HIGH READING WAS ALSO OBTAINED ON THE INFORM SYSTEM. REPORTER STATED THE PT WAS DISCHARGED 6 DAYS LATER. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT REC'D. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK INFORM METER BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention