BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISION QID GLUCOSE METER

    MDR report key: 289142 · Received August 7, 2000

    Report

    Report Number
    1220459-2000-00049
    Event Type
    Death
    Date Received
    August 7, 2000
    Date of Event
    July 8, 2000
    Report Date
    July 26, 2000
    Manufacturer
    MEDISENSE, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    07/06/2000 (THURS.) A PT WAS ADMITTED FROM HOME IN A COLLAPSED STATE, SMELLING STRONGLY OF KETONES. THE PT WAS ADMITTED TO A WARD WHERE THE PT HAD CARDIAC ARRESTED AND WAS SUBSEQUENTLY RESUSCITATED. 07/07/2000 8 A.M. (FRI.) THE PT WAS TRANSFERRED TO THE THEATRE RECOVERY FOR OBSERVATION UNTIL A BED IN ICU BECAME AVAILABLE. 07/07/2000 9 A.M. BOTH LAB AND METER GLUCOSE LEVELS WERE OBTAINED AND INSULIN TITRATION WAS CONTINUED AT 10 UNITS/HR. MEDISENSE READINGS WERE OBTAINED FOR 10 A.M., 12 P.M., AND 1 P.M. AND AVERAGED 30.2 MMOL/L (544 MG/DL) WHICH WAS CONSISTENT WITH EARLIER READINGS. 07/07/2000 12 P.M. THE INSULIN DRIP WAS DECREASED FROM 10 UNITS TO 6 UNITS. 07/07/2000 APPX. 12 P.M. (NOON) PT TRANSFERRED TO "ITU". 07/07/2000 1 P.M. "ITU" STAFF MEMBERS NOTED THE DIFFERENCE IN READINGS OF THE PRECISION QID METER COMPARED TO THE LAB RESULTS FROM EARLIER IN THE MORNING. (9 A.M.) 07/07/2000 2 P.M. INSULIN DRIP WAS INCREASED TO 8 UNITS/HR. ORDERS WERE CHANGED TO LABORATORY GLUCOSE LEVELS EVERY TWO HOURS. AS THE LABORATORY VALUES CAME DOWN THE PRECISION QID VALUES AGREED MORE CLOSELY WITH THE LAB RESULTS. 07/08/2000 (SAT.) THE PT EXPIRED AT 4 P.M. THE CAUSE OF DEATH MAY HAVE BEEN SEPTICEMIA/PNEUMONIA. THE PRECISION QID METER AND STRIPS WERE REMOVED FROM I.C.U. AND SENT FOR EVALUATIONS. THE USE OF THE METER IN THIS CASE WAS A CONTRAINDICATION OF USE AND IS STATED IN LABEL COPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION QID GLUCOSE METER BLOOD GLUCOSE METER CFR MEDISENSE, INC. NA 85099(EXPIRATION DATE:09/2001)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death