BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION PCX

    MDR report key: 385478 · Received March 27, 2002

    Report

    Report Number
    1220459-2002-00024
    Event Type
    Death
    Date Received
    March 27, 2002
    Date of Event
    March 8, 2002
    Report Date
    March 26, 2002
    Manufacturer
    MEDISENSE, INC
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT INVESTIGATION ORIGINATED WHEN A COMPLAINT WAS REC'D STATING THAT A NON DIABETIC NURSING HOME PT HAD BLOOD DRAWN FOR A LABORATORY GLUCOSE LEVEL IN 2002. THE LABORATORY DAMAGED THE SAMPLE AND NOTIFIED THE NURSING HOME THE NEXT DAY. ANOTHER BLOOD SAMPLE WAS DRAWN THE NEXT DAY AND SENT TO THE LABORATORY. TWO DAYS LATER, THE LABORATORY NOTIFIED THE NURSING HOME THAT THIS PT HAD A LABORATORY BLOOD GLUCOSE VALUE OF 932. IMMEDIATELY, A MEDISENSE BLOOD GLUCOSE METER WAS USED TO TAKE THE PT'S BLOOD SUGAR BY A CAPILLARY DRAW. THE READING OBTAINED WAS 159. THE TEST WAS RUN TWICE ON THE MEDISENSE PCX WITH SIMILAR RESULTS. WITHIN HOURS, THE NURSING HOME PT EXPIRED. THE INCIDENT IS BEING INVESTIGATED BY THE NURSING HOME BUT A DEFINITIVE CAUSE OF DEATH HAS NOT BEEN ATTRIBUTED TO BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION PCX BLOOD GLUCOSE METER CFR MEDISENSE, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other COUMADIN, ALTACE, TACRINE.