BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243798 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03202
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 5, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVAL. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM, AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE RPTR/LAYPERSON (GRAND DAUGHTER) ALLEGED THAT THE PT/LAYPERSON'S ONE TOUCH ULTRA METER WAS POWERING OFF AFTER IT WAS TURNED ON. REPORTEDLY, A NEW BATTERY DID NOT RESOLVE THE ISSUE AND ONE OF THE BATTERY CONTACTS APPEARED LOOSE. THE ALLEGED ISSUE BEGAN POSSIBLY THE MONTH PRIOR. THE NIGHT OF THREE DAYS PRIOR TO ORIGINAL DATE, THE PT WAS REPORTEDLY DROWSY AND VOMITING. ALTHOUGH THE REPORTER HAD LOANED HER OWN METER TO THE PT, THE REPORTER HAS NO INFO REGARDING BLOOD GLUCOSE RESULTS OR INSULIN THAT MAY HAVE BEEN TAKEN THAT NIGHT OR DAY. THE FOLLOWING DAY THE PT "FELT LOW" AND WAS "SHAKY". DUE TO THE SYMPTOMS, THE PT ATE RICE AND CEREAL, AND DRANK ORANGE JUICE. AT AN UNK TIME AFTER EATING, THE PT'S DAUGHTER DROVE HER TO AN URGENT CARE FACILITY WHERE THE PT'S BLOOD GLUCOSE WAS 600 OR MORE ON THE PHYSICIAN'S METER HE PHYSICIAN ADVISED THE PT TO GO HOME AND TAKE SOME INSULIN. URGENT CARE DID NOT TREAT THE PT. THE REPORTER HAD NO OTHER INFO TO PROVIDE. TROUBLESHOOTING COULD NOT BE PERFORMED FOR CUSTOMER SVC BECAUSE THE CONTROL SOLUTION WAS EXPIRED. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. BECAUSE THE PT REPORTEDLY COULD NOT OBTAIN AN ACTIONABLE BLOOD GLUCOSE RESULT ON HER OWN METER AND WAS SEEN IN URGENT CARE WHERE HER BLOOD GLUCOSE WAS HIGHER THAN 500 MG/DL, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R