BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243801 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03199
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 3, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED THE REUTURN 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 LAY USER/REPORTER CONTACTED LIFESCAN (LFS) ON BEHALF OF THE LAY-USER/PT ALLEGING THE ONE TOUCH ULTRA METER IS GIVING AN ERROR 5 MESSAGE. ACCORDING TO THE REPORTER, THE ERROR 5 MESSAGE FIRST OCCURRED THE PREVIOUS MONTH. IT IS NOT KNOWN HOW THE PT WAS ABLE TO MAINTAIN HIS DIABETES TREATMENT AFTER THE REPORTED ISSUE BEGAN. TWO MONTHS LATER AT 8:00PM, THE PT REPORTEDLY PASSED OUT AND THE EMERGENCY SERVICE WAS CALLED. UPON ARRIVAL, THE PT OBTAINED A BLOOD GLUCOSE READING OF "40 MG/DL" ON THE EMS METER AND WAS GIVEN GLUCOSE IV. THE DAY PRIOR TO ORIGINAL DATE, THE PT DECREASED HIS DIABETES INSULIN REGIMEN FROM 35 UNITS TO 25 UNITS AT NIGHT AND FROM 50 UNITS TO 10 UNITS DURING THE DAY. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PT'S DIABETES MEDICATION REGIMEN AND TESTING FREQUENCY, THE DURATION OF THE SYMPTOMS, WHAT TREATMENT DID THE PT RECEIVE IN ORDER FOR THE SYMPTOMS TO ABATE, COULD THE SYMPTOMS HAVE BEEN PREVENTED, WAS THE PT'S DIABETES MEDICATION CHANGED IMMEDIATELY BEFORE OR SOMETIME AFTER THE AFOREMENTIONED SYMPTOMS AND THE EVENTS LEADING UP TO THE PT'S MEDICAL INTERVENTION/REPORTED SYMPTOMS SUCH AS BLOOD GLUCOSE READINGS, DIABETES MEDICATION INTAKE, FOOD INTAKE, AND PHYSICAL ACTIVITIES. DURING TROUBLESHOOTING, THE REPORTED ISSUE WAS RESOLVED WITH TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED THAT HE WAS HYPOGLYCEMIC, AND WAS TREATED WITH GLUCOSE IV AFTER THE ERROR 5 ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2866009

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Life Threatening| R