BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3901214 · Received June 30, 2014

    Report

    Report Number
    2939301-2014-15773
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 17, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    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

    ON (B)(6) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE ONETOUCH ULTRA2 METER IS GIVING INACCURATE HIGH OF ¿85 MG/DL¿ COMPARED FEELING/NORMAL READINGS. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2014 AT 12:10 AM, SHE REPORTEDLY TOOK 3 UNITS OF HUMALOG BASED ON AN ALLEGEDLY INACCURATE HIGH LFS METER READING. IN ADDITION, THE PATIENT TOOK 60 UNITS OF LEVEMIR THAT DAY. AROUND 10 HOURS LATER, AT 9:45 AM, THE PATIENT REPORTEDLY DEVELOPED SYMPTOM OF ¿SHAKY¿ AND TESTED ON ANOTHER METER, REPORTEDLY RECEIVING A ¿LOW READING.¿ THERE WAS NO REPORT OF ANY REQUIRED HCP TREATMENT AT THE TIME OF CONCERN. DURING THE TROUBLESHOOTING, THE PATIENT CONFIRMED THE UNIT OF MEASUREMENT WAS SET CORRECTLY AT THE TIME OF TESTING. THE TEST STRIPS WERE GOOD CONDITION AND WITHIN THE DISCARD DATE. THE PATIENT COULD NOT PROVIDE ANY NUMERIC VALUES ON THE OTHER METER. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT DEVELOPED SYMPTOM THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIC AFTER SHE TOOK INSULIN BASED ON THE LFS METER READING. THE LFS PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380753 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3421595

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening