BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1081641 · Received July 22, 2008

    Report

    Report Number
    2939301-2008-01461
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 10, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    THE COMPLAINT IS CLASSIFIED BASED UPON INFORMATION, THE PATIENT/LAYPERSON GAVE TO A CUSTOMER CARE ADVOCATE, CCA, ON JULY 10, 2008. THIS SENIOR MEDICAL AFFAIRS SPECIALIST HAS MAILED A LETTER TO THE PATIENT, HAVING OBTAINED NO RESPONSE WITH CALLS. THE CCA REPLACED THE PRODUCTS. THE PATIENT COMPLAINED THAT HER BLOOD GLUCOSE RESULTS ON HER ONETOUCH ULTRA METER WERE INACCURATELY HIGH COMPARED TO AN EMERGENCY ROOM METER. THE PATIENT ALLEGED THAT ON TWO DAYS EARLIER, SHE WAS "NERVOUS AND BAD." THE PATIENT EITHER REFUSED OR WAS UNABLE TO PROVIDE THE REPORTED ELEVATED RESULT WHEN SHE TESTED. THE PATIENT TOOK HER USUAL DOSE OF ORAL MEDS, 500 MG METFORMIN AND 5 MG GLIPIZIDE. THE PATIENT WAS REPORTEDLY SEEN IN THE ER AROUND 10:30 PM; HOWEVER, THE PATIENT DID NOT INDICATE WHETHER SHE WENT TO THE ER BECAUSE OF THE UNKNOWN ELEVATED RESULT ON HER METER OR BECAUSE OF HOW SHE FELT. THE ER METER TEST REPORTEDLY REVEALED RESULTS OF "110 AND 87" MG/DL. REPORTEDLY, THE PATIENT WAS GIVEN FOOD AND BEVERAGE IN THE ER. THE PATIENT DID NOT PROVIDE THE TIMING OF THE RESULTS, WHETHER BEFORE OR AFTER THE FOOD AND BEVERAGE WAS GIVEN. ALTHOUGH THE PATIENT'S SYMPTOMS BEFORE TESTING ARE NOT ASSOCIATED WITH SEVERE HYPO OR HYPERGLYCEMIA, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT DUE TO TREATMENT WITH FOOD RECEIVED IN THE ER AFTER ALLEGED UNKNOWN ELEVATED RESULTS ON THE PATIENT'S METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2810015

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Life Threatening| H| R