BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH

    MDR report key: 93222 · Received May 23, 1997

    Report

    Report Number
    2939301-1997-00037
    Event Type
    Injury
    Date Received
    May 23, 1997
    Date of Event
    March 8, 1997
    Report Date
    May 23, 1997
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CO HAS COMPLETED CO'S INVESTIGATION OF THE MDR INCIDENT LISTED ABOVE AND AFTER TESTING THE DEVICE, HAVE NOT BEEN ABLE TO VERIFY A DEVICE MALFUNCTION. THE METER READ OUTSIDE OF ITS LABELED CALIBRATION RANGE UPON RECEIPT AT CO. THE METER HAD NOT BEEN PROPERLY CLEANED; THERE WAS DRIED BLOOD PRESENT ON THE OPTIC WINDOW. WHEN THE METER WAS TESTED AS RECEIVED, THE METER DID MEET THE PRODUCT PERFORMANCE SPECIFICATIONS. AFTER CLEANING THE METER OPTICS PER THE INSTRUCTIONS IN THE ONE TOUCH OWNER'S BOOKLET, THE METER READ WITHIN CALIBRATION RANGE. CO CONCLUDES THAT THE ALLEGED INACCURATE LOW TEST RESULTS WERE DUE TO THE USER'S FAILURE TO PROPERLY CLEAN AND MAINTAIN THE METER AND FAILURE TO PERFORM DAILY CALIBRATION CHECKS WHICH ARE INTENDED TO DETECT THIS TYPE OF CONDITION, AS INSTRUCTED IN THE PRODUCT LABELING. AT THIS POINT CO INVESTIGATION OF THIS MATTER IS CLOSED.

    Description of Event or Problem · 1

    WHILE ON TOUR, THE PT, A IDDM, BECAME ILL AND WAS HOSPITALIZED ON 3/8 FOR DIABETIC KETOACIDOSIS WITH A BLOOD GLUCOSE LEVEL OF 313 MG/DL. SHE WAS TREATED WITH IV INSULIN AND SALINE AND RELEASED 3/10. SHE CONTINUED ON HER TOUR AND WAS AGAIN HOSPITALIZED ON 3/12 FOR ELEVATED GLUCOSE. THE PT WAS TREATED WITH SLIDING SCALE INSULIN, MAGNESIUM AND POTASSIUM AND RELEASED 3/15. A GLYCOSYLATED HEMOGLOBIN A1C TEST DONE ON 4/24 WAS 13.8, BELYING THE REPORTED ONE TOUCH RESULTS OF 10 MMOL/L OR LESS. A COMPARISON WAS PERFORMED ON 4/4 WITH A ONE TOUCH BASIC METER. THE ONE TOUCH METER READ 13.5 MMOL/L WHILE AT THE SAME TIME THE ONE TOUCH BASIC METER READ 23.1 MMOL/L. THE METER IS ALLEGEDLY CLEANED ACCORDING TO MFR'S RECOMMENDATIONS AND WAS IN CALIBRATION ON 4/24, READING 4.0 WITHIN A RANGE OF 3.8-5.1.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R