BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT BASIC METER

    MDR report key: 2115839 · Received June 7, 2011

    Report

    Report Number
    2939301-2011-04674
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    November 7, 2010
    Report Date
    May 27, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 510(K) # IS K023948.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (07/08/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A CONTAMINATED BATTERY CONTACT. A SECONDARY ISSUE WAS NOTED, THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH BASIC METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN THE FIRST WEEK OF (B)(6) 2010. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH METFORMIN PILLS (500 MG), NOVOLOG INSULIN (7 UNITS 3X DAILY) AND LANTUS INSULIN (27 UNITS IN THE EVENING). THE PATIENT CONTINUED TO TAKE HER USUAL DOSE OF MEDICATIONS. PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF DIZZINESS, VOMITING AND WEAKNESS. ON THE EARLY MORNING OF (B)(6) 2010, THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND OBTAINED A BLOOD GLUCOSE RESULT OF "560 MG/DL" WITH THE ER/ HOSPITAL METER. THE PATIENT WAS ADMINISTERED INTRAVENOUS (IV) FLUIDS AS TREATMENT AND ADMITTED INTO THE HOSPITAL FOR THE FOLLOWING 3 DAYS PRIOR TO BEING RELEASED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER; HOWEVER, THE BATTERIES NEEDED TO BE REPLACED. 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 BASIC METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R