BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1930897 · Received December 16, 2010

    Report

    Report Number
    2939301-2010-10812
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 12, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. 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.

    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. 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2010. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH 2 TYPES OF ORAL MEDICATION AND 2 TYPES OF INSULIN (TYPES/ AMOUNTS NOT SPECIFIED). THE PATIENT STATED SHE INCREASED HER USUAL DOSE OF MEDICATION (TYPE/ AMOUNT NOT SPECIFIED). AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE FELT "SICK." THAT SAME DAY, EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED AND ADMINISTERED THE PATIENT INSULIN (TYPE/ AMOUNT NOT CLEAR). THE PATIENT STATED SHE OBTAINED A BLOOD GLUCOSE RESULT OF "561 MG/DL" WITH THE EMS DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER. THE CCA TRIED TO WALK THE PATIENT THROUGH RESOLVING THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3057854

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R