BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1133246 · Received August 21, 2008

    Report

    Report Number
    2939301-2008-01920
    Event Type
    Injury
    Date Received
    August 21, 2008
    Report Date
    August 19, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 (LFS) ALLEGING THAT A ONE TOUCH ULTRA 2 METER WAS READING INACCURATELY HIGH. THE PATIENT TESTS HIS BLOOD GLUCOSE TWICE A DAY. HE TESTS BEFORE BREAKFAST AT AROUND 8:00 AM. HE ALSO TESTS BEFORE DINNER BETWEEN 5:00-5:30 PM. HIS NORMAL BLOOD GLUCOSE LEVELS ARE AROUND "98-120 MG/DL." THE PATIENT TAKES HUMULIN 70/30 INSULIN TWO TIMES A DAY. HE TAKES 54 UNITS IN THE MORNING AND 32 UNITS IN THE EVENING. THE PATIENT INDICATED THAT THE ALLEGED METER ISSUE STARTED ABOUT A WEEK OR SO BEFORE HE CONTACTED LFS ON THE SAME DAY. DURING THE TIME OF CONCERN, THE PATIENT MENTIONED THAT HE STARTED GETTING METER READINGS BETWEEN "150-170 MG/DL." AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT DECIDED ON HIS OWN TO INCREASE HIS INSULIN DOSAGES FOR THE PAST 2 WEEKS BY 2 UNITS IN THE MORNING AND ALSO IN THE EVENING. THE PATIENT EXPLAINED THAT WITHIN THOSE 2 WEEKS, HE SUFFERED ABOUT 3 HYPOGLYCEMIC EVENTS WHERE HE ENDED UP DEVELOPING SYMPTOMS OF NERVOUSNESS, AND FEELING SHAKY AND CLAMMY DURING THE MIDDLE OF THE NIGHT AT AROUND 2:00 AM. BEFORE EACH EVENT OCCURRED, THE PATIENT MENTIONED THAT HE HAD EATEN DINNER AND HIS PRE-BEDTIME SNACKS AS USUAL. HE ALSO EXPLAINED THAT HE HAD TAKEN 2 EXTRA UNITS OF INSULIN BEFORE DINNER IN EACH CASE. IN EACH INSTANCE WHERE HE DEVELOPED SYMPTOMS, THE PATIENT ADMINISTERED SELF-CARE BY EATING "SWEETS" WHICH RELIEVED HIS SYMPTOMS. HE DENIED CHECKING HIS BLOOD GLUCOSE WHILE BEING SYMPTOMATIC. THE PATIENT DENIED RECEIVING MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER. THE PATIENT PERFORMED 3 CONTROL SOLUTION TESTS USING TEST STRIPS FROM 2 DIFFERENT VIALS. ALL 3 CONTROL SOLUTION TESTS FAILED HIGH. HE GOT RESULTS OF "128, 127, AND 128 MG/DL." THE CONTROL SOLUTION RANGES WERE "93-124 MG/DL." THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE INCREASED HIS INSULIN DOSES BASED ON THE ALLEGED "INACCURATELY HIGH" READINGS DUE TO THE REPORTED ISSUE AND REPORTEDLY 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2778415

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R