BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1893512 · Received November 8, 2010

    Report

    Report Number
    2939301-2010-09712
    Event Type
    Injury
    Date Received
    November 8, 2010
    Report Date
    October 30, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. 510K #K061118.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LFS CUSTOMER SERVICE. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH ULTRAMINI METER IS GIVING INACCURATE ERRATIC READINGS OF "341, 300, 241, 192, AND 250 MG/DL." THE PATIENT'S DIABETES IS MANAGED WITH ORAL MEDICATION OF GLIPIZIDE. THE PATIENT CLAIMED THAT HE HAS BEEN OBTAINING INACCURATE READINGS ON THE SUBJECT METER FOR 4-5 MONTHS PRIOR TO CONTACTING LFS. BASED ON THE REPORTED HIGH READINGS, THE PATIENT TOOK 1 PILL OF GLIPIZIDE IN THE MORNING TIME, AND 2 PILLS OF GLIPIZIDE IN THE NIGHT TIME. IN ADDITION, THE PATIENT INDICATED THAT HE DECREASED HIS CARBOHYDRATE INTAKE. ABOUT ONE MONTH AFTER THE ONSET OF THE ALLEGED INACCURATE ISSUE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF HIGH AND LOW BLOOD GLUCOSE. AT ONE POINT, THE PATIENT CLAIMED HE WAS "FEELING FAINT, LIKE PASSING OUT." IT WOULD HAVE BEEN HELPFUL TO HAVE MORE DETAILS CONCERNING THE PATIENT'S DIABETES REGIMEN AND THE CIRCUMSTANCES SURROUNDING THE INCIDENT. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE READINGS OF "341, 300, 241, 192, AND 250 MG/DL" WERE PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE DEVELOPED HIGH AND LOW BLOOD SUGAR SYMPTOMS AFTER HE MANAGED HIS DIABETES BASED ON THE ALLEGED INACCURATE LFS METER READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3043957

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening