BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 7302011 · Received February 28, 2018

    Report

    Report Number
    3008382007-2018-00651
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    February 20, 2018
    Report Date
    February 20, 2018
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008167
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018, A REPORTER FOR THE PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRAMINI METER DISPLAYED INACCURATELY HIGH RESULTS COMPARED TO HER FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER ALLEGED THAT AROUND 8PM ON (B)(6) 2018, THE PATIENT OBTAINED AN ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULT ON THE SUBJECT METER OF ¿254 MG/DL¿. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT MANAGES HER DIABETES WITH INSULIN WHICH SHE SELF-ADJUSTS. THE REPORTER STATED THAT BASED ON THE READING OF 254 MG/DL, SHE GAVE THE PATIENT 20 UNITS OF LANTUS INSULIN AT 8PM ON (B)(6) 2018. SHE REPORTED THAT ROUND 2AM ON (B)(6) 2018, THE PATIENT GOT UP, BECAME ¿DELUSIONAL, WASN'T TALKING, WOULDN'T DRINK, WAS MOANING LOUDLY AND FELT SLEEPY¿. THE REPORTER STATED THAT SHE OBTAINED AN ALLEGED INACCURATELY HIGH BLOOD GLUCOSE RESULT ON THE SUBJECT METER OF ¿177 MG/DL¿. SHE REPORTED INDICATED THAT SHE CALLED THE EMERGENCY MEDICAL SERVICE (EMS) FOR FURTHER ASSISTANCE AT 2:10AM. SHE STATED THAT ON ARRIVAL, THE EMS OBTAINED A BLOOD GLUCOSE RESULT OF ¿27 MG/DL¿ ON THE EMS METER. SHE INDICATED THAT THE EMS TEAM GAVE THE PATIENT ¿ORAL GLUCOSE TABLET AND IV CLEAR LIQUID SOLUTION¿ TO TREAT HER SYMPTOMS. SHE REPORTED THAT AFTER A COUPLE OF MINUTES, EMS OBTAINED A FURTHER READING OF ¿137 MG/DL¿ ON THE EMS METER AND THE PATIENT ¿BECAME STABLE¿. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE. HOWEVER, THE CCA ALSO NOTED THAT THE PATIENT¿S TEST STRIPS HAD EXPIRED IN FEBRUARY 2016, INVALIDATING THE RESULTS OBTAINED. EDUCATION WAS PROVIDED BY THE CCA ON THE CORRECT TEST STRIP STORAGE AND THE USE OF CONTROL SOLUTION. REPLACEMENT PRODUCTS, AND CONTROL SOLUTION, WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR AN ACUTE LOW BLOOD GLUCOSE EXCURSION WHILE USING THE METER AND (EXPIRED) TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146451 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3668785 00353885008167

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening| R