BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1013949 · Received March 14, 2008

    Report

    Report Number
    2939301-2008-00309
    Event Type
    Injury
    Date Received
    March 14, 2008
    Report Date
    February 16, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER, STRIPS, AND/OR CONTROL SOLUTION ARE RETURNED. LIFESCAN WILL EVALUATE THEM AND, IF EITHER THE METER, STRIPS, OR CONTROL SOLUTION 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/PATIENT CONTACTED LIFESCAN ALLEGING THAT A ONE TOUCH ULTRA METER FAILED A CONTROL SOLUTION TEST HIGH. IT IS NOT CLEAR AS TO WHAT A DATE/TIME THE ALLEGED ISSUE STARTED. THE PATIENT REPORTED A CONTROL SOLUTION RESULT OF "148 MG/DL". THE REPORTED CONTROL SOLUTION RANGE WAS "108-144 MG/DL". THE PATIENT DID NOT TAKE ANY ACTIONS RELATED TO DIABETES TREATMENT AS A RESULT OF THE REPORTED ISSUE. ON AN UNSPECIFIED DATE/TIME AFTER THE ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF BLURRED VISION, AND FEELING HIGH AND "FUNNY". THE PATIENT DENIED RECEIVING MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER DURING THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, WHEN THE ALLEGED ISSUE STARTED, WHAT ACTIONS THE PATIENT TOOK IN RESPONSE TO THE REPORTED ISSUE, AND WHAT ACTIONS THE PATIENT TOOK BEFORE, DURING, AND AFTER THE TIME HE DEVELOPED THE SYMPTOMS. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO NOW WHAT THE PATIENT'S LAST BLOOD GLUCOSE RESULT WAS BEFORE THE EVENT, WHEN THE TEST WAS PERFORMED, IF THE PATIENT TESTED HIS BLOOD GLUCOSE BEFORE AND DURING THE TIME HE HAD SYMPTOMS, HIS MEDICATION AND DIABETES MANAGEMENT REGIMENS, AND IF THE PATIENT MADE ANY CHANGES TO THE REGIMENS BECAUSE OF THE ALLEGED ISSUE. THE PATIENT WAS USING THE CORRECT CONTROL SOLUTION BUT WAS NOT USING A CORRECT TECHNIQUE. SHE DID NOT HAVE ADDITIONAL CONTROL SOLUTION FOR TROUBLESHOOTING. THE METER WAS REPLACED. ALTHOUGH THE PATIENT DID NOT MAKE ANY ALLEGATIONS RELATED TO BLOOD GLUCOSE RESULTS, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPERGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN. IT IS NOT CLEAR AS TO WHAT ACTIONS THE PATIENT TOOK IN RESPONSE TO THE ALLEGED ISSUE AND BEFORE SHE DEVELOPED THE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2644152

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening