BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCH ULTRAMINI METER

    MDR report key: 1092886 · Received July 31, 2008

    Report

    Report Number
    2939301-2008-01604
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 16, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    ON JULY 16, 2008, A PATIENT/LAYPERSON INFORMED A CUSTOMER CARE ADVOCATE, CCA, THAT HIS ONETOUCH ULTRAMINI WOULD NOT TURN ON. BECAUSE THE PATIENT HAS NOT RESPONDED TO CALLS, THIS SENIOR MEDICAL AFFAIRS SPECIALIST HAS SENT A LETTER. THE COMPLAINT IS CLASSIFIED BASED UPON INFORMATION THE PATIENT GAVE TO THE CCA WHO REPLACED THE METER. THE PATIENT, WHO TESTS TWICE A DAY AND WHOSE REGIME IS ORAL DIABETES MEDICATION, REPORTEDLY PURCHASED THE METER 4-5 WEEKS EARLIER. IN 2008, THE METER REPORTEDLY WOULD NOT TURN ON. WITH A NEW BATTERY, IT ALLEGEDLY STILL WOULD NOT TURN ON. AFTER THE ISSUE BEGAN, TIME AND DATE NOT PROVIDED, THE PATIENT ALLEGEDLY HAD PAINS IN HIS CHEST AND WAS SHAKY AND DISORIENTED. A TEST ON A "BAYER BRAND METER WAS 227." THE PATIENT DID NOT INDICATE WHETHER THE OTHER METER IS HIS. REPORTEDLY, THE PATIENT RECEIVED NO MEDICAL INTERVENTION. IT WOULD BE HELPFUL TO KNOW WHAT TRANSPIRED BEFORE AND AFTER THE ALLEGED 227 BLOOD GLUCOSE AND DURING THE SYMPTOMS. BECAUSE THE PATIENT ALLEGED THAT HE EXPERIENCED SHAKINESS (A SYMPTOM THAT TYPICALLY IS ASSOCIATED WITH SEVERE HYPOGLYCEMIA) AFTER THE ISSUE BEGAN, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2812160

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening