BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1030745 · Received April 17, 2008

    Report

    Report Number
    2939301-2008-00587
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 30, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER 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 PATIENT/LAYPERSON ALLEGED TO A CUSTOMER CARE ADVOCATE, CCA, THAT HER ONETOUCH ULTRAMINI RESULTS WERE INACCURATELY HIGH, RESULTING IN OVERMEDICATING FOLLOWED BY HYPOGLYCEMIA. THE CCA REPLACED ALL PROUDCTS. THIS SENIOR MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE PT ON THE FOLLOWING MONTH. RESULTS ARE IN THE CORRECT UNIT OF MEASURE, MG/DL. THE PT WAS CONCERNED THAT SHE HAS BEEN HAVING FREQUENT HYPOGLYCEMIC EVENTS AFTER INJECTING INSULIN BASED UPON HER METER RESULTS. ALTHOUGH NOT A NEW OCCURRENCE, SHE HAS BEEN HYPOGLYCEMIC MORE OFTEN SINCE HER PHYSICIAN, ON ELEVEN DAYS PRIOR TO ORIGINAL DATE, ADDED 15 UNITS HUMALOG TO BE TAKEN AT BREAKFAST, LUNCH AND DINNER AS WELL AS 60 UNITS LANTUS AT BEDTIME BESIDES HER USUAL HUMALOG ON A SLIDING SCALE. THE PT SELF-TREATED DRUING THE HYPOGLYCEMIC EPISODES IN WHICH HER SYMPTOMS WERE SHAKING, POUNDING HEART, COLD SWEATS, AND CONFUSION. ON ONE OCCASION, A TEST STRIP ALSO PEELED WHEN PLACING IT INTO THE TEST PORT. WHILE HYPOGLYCEMIC ONE OF THE PT'S SELF-TESTS WERE 45 AND 37, REFLECTING HER SYMPTOMS. THE PT IS TO REMAIN ON THE NEW REGIMEN FOR 21 DAYS AND THEN FOLLOW UP WITH THE DR. THE PT IS ASYMPTOMATIC WHEN BOTH HYPER AND HYPOGLYCEMIC, AND SUFFERS FROM NON-ALCOHOLIC RELATED CIRRHOSIS OF THE LIVER. IT IS NOT CLEAR THAT THE PRODUCT IS MALFUNCTIONING, OR THAT THE PT'S CURRENT INSULIN REGIME MAY NEED DECREASING. HER RECENT HEMOGLOBIN A1C OF 13.4 REFLECTS ELEVATED BLOOD GLUCOSE. NEVERTHELESS, THE COMPLAINT IS CLASSIFIED, AS AN ADVERSE EVENT BECAUSE THE PT STATED SHE INCREASED HER INSLIN BASED UPON THE METER'S RESULTS AND EXPERIENCED HYPOGLYCEMIA AFTERWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2781859

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening