BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4911530 · Received July 14, 2015

    Report

    Report Number
    2939301-2015-29329
    Event Type
    Injury
    Date Received
    July 14, 2015
    Report Date
    July 6, 2015
    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
    CA, US
    Reporter Occupation
    003

    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) 2015, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER TESTED IN SETTINGS MODE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED PRODUCT ISSUE BEGAN ON (B)(6) 2015 (TIME NOT PROVIDED). THE PATIENT MANAGES HIS DIABETES WITH ORAL DIABETES MEDICATIONS WITH DIET AND/OR EXERCISE. THE REPORTER STATED THAT THE PATIENT TOOK HIS USUAL DOSE OF METFORMIN 1 G AND JANUVIA 100 MG MEDICATION (INCLUDING SLIDING SCALE) ON (B)(6) 2015 AT 10:00AM AND AGAIN AT 5:00PM (METFORMIN ONLY) IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED THE SYMPTOMS OF "SWEATING, LIGHTHEADED AND SHAKINESS" 24 HOURS AFTER THE ALLEGED PRODUCT ISSUE BEGAN; HOWEVER, SHE DENIED THAT THE PATIENT RECEIVED MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE ISSUE WAS RESOLVED WITH WALK-THROUGH RETEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE, THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED THE SYMPTOMS OF "SWEATING, LIGHTHEADED AND SHAKINESS" AFTER THE ALLEGED PRODUCT ISSUE BEGAN. THESE SYMPTOMS DO MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455820 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3789371

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening