BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1060277 · Received June 10, 2008

    Report

    Report Number
    2939301-2008-01047
    Event Type
    Injury
    Date Received
    June 10, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 24, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THE ONETOUCH ULTRAMINI METER HAD AN APPLY SAMPLE ISSUE. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CORRESPOND WITH THE PATIENT BY TELEPHONE ON JUNE 9, 2008 AND CLASSIFIED THE COMPLAINT BASED ON THE FOLLOWING INFORMATION RECEIVED FROM THE CUSTOMER. THE PATIENT TESTS HER BLOOD GLUCOSE 4 TIMES A DAY BEFORE MEALS AND AT BEDTIME. SHE MANAGES HER DIABETES VIA LANTUS 15 - 18 UNITS ON A FIXED AMOUNT AT NIGHT AND HUMALOG 5 - 10 UNITS ON A SLIDING SCALE BASED ON THE METER READING. THE PATIENT STATED THAT THE ALLEGED METER ISSUE BEGAN ON FIVE DAYS PRIOR TO ORIGINAL DATE, 2008 BETWEEN 4:15PM AND 5PM. THE PATIENT REPORTEDLY EXPERIENCED SYMPTOMS OF "LOW BLOOD GLUCOSE, SWEATING AND CONFUSION" WHICH DEVELOPED AFTER THE ALLEGED METER ISSUE BEGAN. THE PATIENT REPORTEDLY TOOK ORANGE JUICE TO RELIEVE THE SYMPTOMS. ON THE NEXT DAY IN THE MORNING, SHE RECEIVED ASSISTANCE FROM HER DOCTOR AND WAS TESTED LOW (UNKNOWN METER READING) ON THE DOCTOR'S METER. THE PATIENT REPORTEDLY DID NOT RECEIVE/ REQUIRE ANY TREATMENT FOR THE DIABETES. AS PER THE REQUEST MADE TO THE DOCTOR, THE PATIENT WAS REFERRED TO AN ENDOCRINOLOGIST. THE FUTURE APPOINTMENT WITH THE SPECIALIST IS ON APPROX TWO MONTHS LATER. DURING THE TROUBLESHOOTING THE CCA FOUND OUT THAT THE PATIENT WAS USING THE CORRECT TECHNIQUE FOR THE SAMPLE APPLICATION, THE TEST STRIP DREW THE SAMPLE INTO THE TEST AREA AND WHEN RETESTED WITH A NEW VIAL OF TEST STRIPS THE ISSUE WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT THE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2784754

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening