BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1613818 · Received February 3, 2010

    Report

    Report Number
    2939301-2010-00518
    Event Type
    Injury
    Date Received
    February 3, 2010
    Date of Event
    January 8, 2010
    Report Date
    January 18, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    LAY USER/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.

    Description of Event or Problem · 1

    THIS SENIOR MEDICAL SURVEILLANCE SPECIALIST REVIEWED THE CUSTOMER CARE ADVOCATE'S (CCA'S) DOCUMENTATION. ON (B) (6) 2010, THE PATIENT/LAYPERSON COMPLAINED THAT HER ONETOUCH ULTRAMINI BLOOD GLUCOSE RESULTS ON (B) (6) 2010 WERE INACCURATELY HIGH COMPARED TO HER NORMAL RESULTS, PROVIDING 374, 243, 213, 333, AND 345 MG/DL. THE PATIENT DID NOT INDICATE WHETHER SHE WAS SYMPTOMATIC AT THE TIME OF TESTING. AT 8:30 PM ON (B) (6) 2010, THE PATIENT TESTED AFTER EATING DINNER, RESULT 345. ALTHOUGH THE PATIENT'S EVENING DOSE OF HUMULIN R IS 25 UNITS AND METFORMIN IS 1,000 MG, THE PATIENT STATED, "I COVERED THE HIGH READINGS AND TOOK TOO MUCH INSULIN", IMPLYING THAT SHE INJECTED EXTRA. AT 2 A.M. OR BEFORE ON (B) (6) 2010, THE PATIENT'S HUSBAND HEARD HER "BREATHING FUNNY"; SHE ONLY WAS UNRESPONSIVE. SHORTLY THEREAFTER, EMT WAS SUMMONED AND ARRIVED, OBTAINING "8" MG/DL ON THE EMT METER, TYPE NOT KNOWN. THE PATIENT WAS GIVEN AN INJECTION OF GLUCAGON AND TRANSPORTED TO THE HOSPITAL. BECAUSE, THE PATIENT ALLEGED THAT SHE WAS TREATED FOR HYPOGLYCEMIA AFTER TAKING "TOO MUCH INSULIN" BASED UPON AN ELEVATED METER READING, THE COMPLAINT IS REPORTED. THE PATIENT HAD NO CONTROL SOLUTION TO TROUBLESHOOT. CCA REPLACED THE METER, STRIPS, AND CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2955715

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R