BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2192512 · Received August 5, 2011

    Report

    Report Number
    2939301-2011-06910
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN INACCURATE HIGH ISSUE WITH HIS ONE TOUCH ULTRA METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON (B)(6) 2011, AT 7AM. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "170 MG/DL" WITH THE SUBJECT METER AND "30 MG/DL" ON A LABORATORY DEVICE, PERFORMED GREATER THAN 30 MINUTES OF EACH OTHER. IT IS UNKNOWN IF BETWEEN THE TESTS THERE WAS ANY KIND OF INTERVENTION THAT WOULD CHANGE THE BLOOD GLUCOSE. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH METFORMIN AND HUMULIN 70/30. IN RESPONSE TO THE ALLEGED INACCURATE HIGH RESULT, BETWEEN 8-8:30 AM, HE INCREASED HIS DOSE OF MEDICATION WITH ONE PILL OF METFORMIN (UNKNOWN DOSE) AND 35U OF HUMULIN 70/30. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS DUE TO THE ALLEGED PRODUCT ISSUE. IN RESPONSE TO THE LAB'S LOW RESULT, AT 8AM, HE WAS TREATED BY A NURSE AT THE (B)(6) CENTER WITH FOOD AND DRINK. ON (B)(6) 2011, HE VISITED HIS DIABETIC DOCTOR FOR A FOLLOW UP AND WAS INSTRUCTED TO CALL LFS TO DISCUSS THE SUBJECT METER'S ALLEGED INACCURATE HIGH READING. NO OTHER DEVICE WAS AVAILABLE AT TIME OF CONCERN. DURING INITIAL CALL WITH CUSTOMER SERVICE, THE CCA NOTED THAT THE PATIENT WAS USING THE CORRECT UNIT OF MEASURE IN THE METER AND WAS ALSO USING AN ADEQUATE SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FOR ACUTE COMPLICATIONS SUGGESTIVE OF HYPOGLYCEMIA 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention