BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1834308 · Received September 14, 2010

    Report

    Report Number
    2939301-2010-07926
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    August 21, 2010
    Report Date
    August 23, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K # IS K053529.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) 2010, THE LAY USER/PATIENT'S FRIEND CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER WAS PROMPTING THE METER SETTINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE PATIENT AND/OR REPORTER BY PHONE. THE PATIENT'S FRIEND REPORTED THAT THE ALLEGED THE SUBJECT METER, THE PATIENT HAD DEVELOPED SYMPTOMS OF "HIGH GLUCOSE A ISSUE BEGAN ON (B)(6) 2010. THE REPORTER STATED THAT ON AN UNSPECIFIED DAY, PRIOR TO OBTAINING ND PAIN IN HIS STOMACH". THE REPORTER STATED THAT AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2010 WHERE HE WAS TREATED WITH INSULIN BY A HEALTHCARE PROFESSIONAL. THE PATIENT'S FRIEND CONFIRMED THAT THE PATIENT'S BLOOD GLUCOSE WAS TESTED ON A HOSPITAL/ER METER; HOWEVER, SHE DID NOT RECALL THE READING OBTAINED. AT THE TIME OF TROUBLESHOOTING, THE REPORTER STATED THAT THE PATIENT RECEIVED THE SUBJECT METER FROM A CLINIC WITH NO INSTRUCTIONS REGARDING HOW TO USE IT. THE CCA NOTED THAT THE ALLEGED ISSUE WAS RESOLVED AFTER THE REPORTER WAS EDUCATED ON THE CORRECT TESTING PROCEDURE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY WAS TREATED WITH INSULIN BY AN HCP AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3023688

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R