BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1872983 · Received October 18, 2010

    Report

    Report Number
    2939301-2010-09151
    Event Type
    Injury
    Date Received
    October 18, 2010
    Report Date
    October 1, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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.THE 510K # K062195.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 11/19/2010. THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. HOWEVER A SECONDARY ISSUE WAS NOTED AS DATA CORRUPTION. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CLASSIFIED THIS COMPLAINT BASED ON CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE ONETOUCH® ULTRA METER DOES NOT TURN ON. THE PATIENT'S DIABETES IS MANAGED WITH JANUVIA AND METFORMIN ORAL MEDICATION. THE POWER ISSUE BEGAN APPROXIMATELY ON (B)(6) 2010. THE PATIENT CONTINUED TO TAKE HER USUAL MEDICATION DESPITE THE PRODUCT ISSUE. ON (B)(6) 2010, THE PATIENT WENT FOR A DOCTOR'S OFFICE WHERE SHE HAD HER BLOOD GLUCOSE TESTED. THE PATIENT COULD NOT PROVIDE THE NUMERIC RESULTS AT THE DOCTOR'S OFFICE. NO MEDICAL TREATMENT WAS REQUIRED AT THE TIME OF CONCERN. AROUND (B)(6) 2010, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF "HEADACHE AND THIRST." ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE POWER ISSUE WAS NOT RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA 8 DAYS AFTER THE POWER ISSUE BEGAN.

    Description of Event or Problem · 1

    THE (B)(6) FEMALE PATIENT WAS PART OF THE (B)(6) STUDY. THE PATIENT RECEIVED A PRECISE STENT IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. DURING POST-DILATATION IN THE INDEX PROCEDURE, THE PATIENT HAD APHASIA WHICH WAS DIAGNOSED AN ISCHEMIC STROKE. EMERGENT CEA SURGERY WAS PERFORMED. PATIENT PARTIALLY RECOVERED AND HAD MAJOR RESIDUALS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening