BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2250601 · Received September 16, 2011

    Report

    Report Number
    2939301-2011-09132
    Event Type
    Injury
    Date Received
    September 16, 2011
    Report Date
    September 9, 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

    DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS ALSO BEEN RETURNED; HOWEVER, TESTING WAS NOT PERFORMED SINCE THE PRODUCT WAS EXPIRED AT THE TIME OF THE COMPLAINT. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS 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. THE 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HE WAS EXPERIENCING A POWER ISSUE WITH HIS ONE TOUCH ULTRA METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT COULD NOT RECALL WHEN THE ALLEGED ISSUE WITH THE SUBJECT METER NOT TURNING ON BEGAN. HE STATED THAT HE MANAGES HIS DIABETES WITH PILLS, DIET AND/OR EXERCISE AND DUE TO THE ALLEGED ISSUE DENIED MAKING ANY CHANGES TO HIS USUAL TREATMENT. THE PATIENT CLAIMED ON AN UNSPECIFIED DAY AND TIME, AFTER THE ALLEGED ISSUE STARTED, HE FELT SWEATY, SHAKY AND HAD A HEADACHE. REPORTEDLY ON AN UNSPECIFIED DAY AND TIME, THE PATIENT'S GLUCOSE WAS TESTED WITH A CLINIC'S METER AND A RESULT OF '172 MG/DL' WAS OBTAINED. HE STATED THAT BASED ON THE CLINIC'S METER RESULT, HE SELF TREATED WITH ORAL MEDICATION (TYPE AND DOSE UNKNOWN). DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE METER'S BATTERY WAS DUE FOR REPLACEMENT. HOWEVER, THE PATIENT DID NOT HAVE A NEW BATTERY AVAILABLE AT THE TIME OF CONCERN. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening