BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOMETER DEX BLOOD GLUCOSE METER

    MDR report key: 286800 · Received July 19, 2000

    Report

    Report Number
    MW1019335
    Event Type
    Injury
    Date Received
    July 19, 2000
    Date of Event
    July 15, 2000
    Report Date
    July 19, 2000
    Manufacturer
    BAYER CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS PT WITH TYPE 1 DIABETES AND RENAL FAILURE HAD MISSED A DOSE OF INSULIN THE NIGHT BEFORE. ON SATURDAY MORNING PT FELT ILL AND WAS PERSPIRING, A SYMPTOM THAT SUGGESTED HYPOGLYCEMIA TO THEM. PT TESTED BLOOD GLUCOSE WITH AMES GLUCOMETER DEX METER AND OBTAINED A READING WHICH SAID: "ERROR 52". PT COULD NOT FIND AN INTERPRETATION OF THIS IN MANUAL AND ASSUMED THIS MEANT THAT GLUCOSE WAS 52 MG/DL. PT SKIPPED MORNING INSULIN AS WELL AND WAITED UNTIL NOON TO RECHECK BLOOD GLUCOSE. PT GOT THE SAME RESULT AND CALLED THE CO TECH SUPPORT NUMBER. PT WAS TOLD THAT THIS ERROR MESSAGE INDICATED THAT THE GLUCOSE WAS VERY HIGH. PT CAME TO THE HOSP AND WAS FOUND TO HAVE A PLASMA GLUCOSE OF OVER 1300 MG/DL AND OTHER ACUTE METABOLIC ABNORMALITIES RELATED TO ACUTE DETERIORATION IN BLOOD GLUCOSE CONTROL WHICH REQUIRED HOSPITALIZATION. PT QUICKLY TREATED AND DID WELL, GOING HOME 2 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER DEX BLOOD GLUCOSE METER HOME BLOOD GLUCOSE MONITORING DEVICE CFR BAYER CORP. 3952B *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R