BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH

    MDR report key: 38272 · Received September 12, 1996

    Report

    Report Number
    2939301-1996-00007
    Event Type
    Injury
    Date Received
    September 12, 1996
    Date of Event
    August 7, 1996
    Report Date
    September 12, 1996
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 8/7 AT 5/A, THE PT AWOKE AND "HER HEAD FELT LIKE IT WAS GOING TO EXPLODE." SHE HAD BEEN OBTAINING READINGS IN THE "LOW 100'S FOR THE PAST TWO AND 1/2 WEEKS ON HER METER AND HAD CEASED TAKING HER INSULIN. HER HUSBAND TOOK HER TO SEE PHYSICIAN WHERE HER BLOOD PRESSURE WAS REPORTED TO BE 250/140 AND HER FASTING GLUCOSE WAS VERY HIGH (RESULT AND METHOD UNKNOWN). SHE WAS TAKEN STRAIGHT TO THE HOSP WHEN A NURSE TOLD THE PHYSICIAN THAT THE PT'S METER WAS 130-150 POINTS OFF FROM THE LAB (RESULTS UNKNWON). THE PT WAS ADMITTED FOR HYPERGLYCEMIA AND TREATED WITH 7U OF R INSULIN "MORE THAN TWO TIMES A DAY." SHE WAS RELEASED FROM THE HOSP ON 8/14. IT IS UNKNOWN HOW THE METER IS MAINTAINED. A CALIBRATION TEST WAS PERFORMED ON 8/13 INDICATING THAT THE METER WAS OUT OF CALIBRATION. THE RESULT WAS 59 VERSUS A RANGE OF 74-100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BLOOD GLUCOSE MONITORING METER CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R