BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1020931 · Received March 27, 2008

    Report

    Report Number
    2939301-2008-00396
    Event Type
    Injury
    Date Received
    March 27, 2008
    Report Date
    March 2, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 WAS GIVING RESULTS OF "0" AND "1" MG/DL. ACCORDING TO THE OWNER'S MANUAL, THE DEVICE HAS NUMERIC RESULT RANGE OF "20-600 MG/DL." THE PATIENT INDICATED THAT THE ALLEGED METER ISSUE STARTED ON AN UNSPECIFIED DATE/TIME IN THE MONTH BEFORE. AS A RESULT OF THE REPORTED ISSUE, THE PATIENT TOOK HIS USUAL DOSAGE(S) OF HUMULIN 70/30 INSULIN. ON AN UNSPECIFIED DATE/TIME AFTER THE REPORTED ISSUE BEGAN, THE PATIENT DEVELOPED SYMPTOMS OF FEELING LOW AND SWEATY. THE PATIENT'S BLOOD GLUCOSE WAS TESTED ON ANOTHER UNIDENTIFIED DEVICE DURING THE TIME OF CONCERN, BUT THE RESULT(S) OBTAINED WERE NOT PROVIDED OR KNOWN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE FOLLOWING INFORMATION: THE PATIENT'S TESTING FREQUENCY, HIS MEDICATION AND DIABETES MANAGEMENT REGIMENS, AND WHAT/DATE TIME THE PATIENT'S SYMPTOMS DEVELOPED. IN ADDITION, IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT DATES/TIMES, THE PATIENT OBTAINED THE REPORTED METER RESULTS, HOW THE PATIENT INTERPRETED THE METER RESULTS, AND WHAT ACTIONS THE PATIENT TOOK BEFORE AND AFTER HE DEVELOPED THE REPORTED SYMPTOMS. THE ALLEGED METER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE PATIENT DID NOT CONTROL SOLUTION. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2650383

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening