BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1890385 · Received November 3, 2010

    Report

    Report Number
    2939301-2010-09662
    Event Type
    Injury
    Date Received
    November 3, 2010
    Report Date
    October 13, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    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. A 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRAMINI METER DISPLAYS AN ERROR 5 MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/ PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2010 (AT 8 AM). THE PATIENT MANAGES HIS DIABETES WITH INSULIN (NO ADJUSTMENTS); TESTING FREQUENCY IS NOT KNOWN. ON (B)(6) 2010 (AT 1 PM) IN RESPONSE TO THE REPORTED METER ISSUE, THE PATIENT STATED HE EXERCISED; IT IS NOT SPECIFIED IF THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT PRIOR TO HIS ACTION AND IT IS NOT KNOWN IF THE PATIENT MADE AN ADDITIONAL CHANGES TO HIS DIABETES MANAGEMENT AFTER THE REPORTED METER ISSUE BEGAN. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS OF "URINATING A LOT, HUNGRY, DIZZINESS" ON AN UNSPECIFIED DATE/TIME (SIX WEEKS LATER); BLOOD GLUCOSE RESULTS PRIOR TO THE ONSET OR DURING HIS SYMPTOMS ARE NOT SPECIFIED. ON (B)(6) 2010 (12:30 PM) THE PATIENT INFORMED THE CSR THAT DURING A DOCTOR'S OFFICE VISIT, HIS BLOOD GLUCOSE WAS TESTED (RESULT UNKNOWN) WITH THE DOCTOR/CLINIC'S METER; HOWEVER, MEDICAL INTERVENTION BY AN HCP WAS NOT SPECIFIED. IT IS NOT KNOWN IF THE PATIENT RECEIVED MEDICAL INTERVENTION OR TREATMENT AFTER THE ALLEGED ISSUE BEGAN AND THE DURATION OF THE PATIENT'S REPORTED SYMPTOMS ARE NOT SPECIFIED. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THE SUBJECT METER WAS NOT CODED PROPERLY (PER OWNER'S BOOKLET RECOMMENDATION) AND THE TEST STRIPS WERE OPEN LONGER THAN THE DISCARD DATE OR STORED IMPROPERLY. DURING TROUBLESHOOTING, THE CSR GUIDED THE PATIENT THROUGH A RETEST (WITH NEW UNEXPIRED TEST STRIPS) AND THE ALLEGED ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3035821

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening