BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1032817 · Received April 21, 2008

    Report

    Report Number
    2939301-2008-00602
    Event Type
    Injury
    Date Received
    April 21, 2008
    Report Date
    April 3, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, 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

    THE LAY USER/PATIENT CONTACTED LIFESCAN IN 2008, AND ALLEGED THAT HIS ONE TOUCH ULTRA METER WAS POWERING OFF DURING USE. THE MEDICAL AFFAIRS SPECIALIST WAS NOT ABLE TO REACH THE PATIENT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. IT IS UNKNOWN WHEN THE REPORTED ISSUE FIRST BEGAN. THE PATIENT REPORTED THAT HE WAS LETHARGIC BEFORE THE REPORTED ISSUE BEGAN. AS A RESULT OF THE REPORTED ISSUE, HE TOOK HIS USUAL DOSE OF DIABETES MEDICATION. THE PATIENT ALSO MENTIONED THAT ABOUT 2 WEEKS AGO, HE HAD TO GO TO THE HOSPITAL BECAUSE HE COULD NOT OBTAIN A RESULT ON HIS METER DUE TO THE ISSUE. HIS BLOOD GLUCOSE LEVEL AT THE HOSPITAL WAS "OVER 600" MG/DL. IT IS NOT CLEAR IF THE HOSPITAL METER RESULT WAS TAKEN BEFORE OR AFTER THE REPORTED ISSUE AND THE SYMPTOMS BEGAN. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW METER. IT WAS DISCOVERED THAT THE PATIENT HAD NOT REPLACED THE BATTERY PER THE OWNER'S MANUAL (USE ERROR). HE WAS ALSO INSERTING THE TEST STRIP INTO THE METER INCORRECTLY (USE ERROR). THE PATIENT WAS EDUCATED ON AUTOMATIC SHUT-OFF; HOWEVER, HE WAS UNABLE/UNWILLING TO ANSWER IF THE METER SHUT OFF BEFORE THE TIME WAS UP. THIS COMPLAINT IS BEING REPORTED BECAUSE ALTHOUGH THE PATIENT REPORTED HE WAS LETHARGIC PRIOR TO THE START OF THE REPORTED ISSUE, HE CLAIMED THAT HE WAS NOT ABLE TO OBTAIN A RESULT ON HIS METER DUE TO THE ALLEGED ISSUE AND HIS BLOOD GLUCOSE LEVEL AT THE HOSPITAL WAS "OVER 600" MG/DL. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2782912

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L