BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1060357 · Received June 17, 2008

    Report

    Report Number
    2939301-2008-01067
    Event Type
    Injury
    Date Received
    June 17, 2008
    Report Date
    May 30, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND TEST STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER HAD REVERTED TO THE SETUP MODE. IT IS NOT CLEAR AS TO WHEN THE ALLEGED METER ISSUE BEGAN. AS A RESULT OF THE REPORTED ISSUE, THE PT REPORTEDLY ADMINISTERED SELF-CARE BY TAKING AN EXTRA 5 UNITS OF HUMALOG INSULIN. THE PT CLAIMED THAT HE DEVELOPED UNSPECIFIED "LOW SUGAR SYMPTOMS" BECAUSE OF THE METER ISSUE AT 4:00 AM (EST). HOWEVER, IT IS NOT KNOWN WHAT DATE THE SYMPTOMS DEVELOPED. THE PT DENIED RECEIVING MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER. HE WAS NOT TESTED ON ANOTHER DEVICE DURING THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFO: THE PT'S TESTING FREQUENCY, HIS DIABETES MANAGEMENT REGIMEN, APPROX. HOW LONG AGO THE METER ISSUE STARTED, WHAT SYMPTOMS HE HAD, AND APPROX WHEN THE SYMPTOMS DEVELOPED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT ACTIONS THE PT TOOK BEFORE AND AFTER THE SYMPTOMS DEVELOPED, WHY THE PT TOOK AN EXTRA 5 UNITS OF INSULIN, AND WHAT HIS LAST SUCCESSFUL READING WAS BEFORE THE METER ISSUE BEGAN. THE REPORTED METER ISSUE APPARENTLY OCCURRED AFTER THE PT REPLACED THE METER'S BATTERY. THE ONE TOUCH CUSTOMER ADVOCATE (OTCA) WALKED THE PT THROUGH SETTING UP THE METER'S SETTINGS. THE METER AND TEST STRIPS WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT HE DEVELOPED SYMPTOMS OF LOW BLOOD GLUCOSE AFTER THE ALLEGED METER ISSUE BEGAN. IT IS NOT KNOWN WHAT SPECIFIC SYMPTOMS THE PT HAD OR WHAT DURATION OF TIME THE ALLEGED METER ISSUE HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2810299

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening