BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRASMART METER

    MDR report key: 2331228 · Received November 10, 2011

    Report

    Report Number
    2939301-2011-10923
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Date of Event
    November 1, 2011
    Report Date
    November 2, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. THE 510(K) # IS K021819.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 11/14/2011 AND 11/15/2011 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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 PATIENT/LAY-USER CONTACTED LIFESCAN (LFS) ALLEGING THAT HE WAS EXPERIENCING AN INACCURATE HIGH ISSUE WITH HIS ONE TOUCH ULTRASMART METER. 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. HE OBTAINED GLUCOSE RESULTS OF '77 MG/DL' ON THE SUBJECT METER, AND '44 MG/DL' ON ANOTHER METER, DONE LESS THAN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. HE STATED THAT HE MANAGES HIS DIABETES WITH HUMALOG (SELF ADJUSTER) AND DUE TO THE ALLEGED INACCURATE HIGH RESULTS ON (B)(6) 2011, AT 10:30 AM, HE INCREASED THE DOSE OF HIS HUMALOG MEDICATION BY 15U MORE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS DUE TO THE ALLEGED ISSUE. IN RESPONSE TO THE HIGH INACCURATE RESULTS, ON (B)(6) 2011, AT 7 AM HE WAS IN THE EMERGENCY ROOM WHERE HIS BLOOD GLUCOSE WAS TESTED WITH THE ER METER AND RESULT OF '44 MG/DL' WAS OBTAINED (AS MENTIONED EARLIER). THE PATIENT REPORTEDLY SELF TREATED WITH FOOD AND/OR DRINK ON (B)(6) 2011, AT 7 AM. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE METER SET TO THE CORRECT UNIT OF MEASURE, AN APPROVED SAMPLE SITE, CORRECT TESTING TECHNIQUE, AND GOOD UNEXPIRED TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER WHEN COMPARED TO A HEALTH CARE PROFESSIONALS METER RESULT OF '44 MG/DL', WHICH REQUIRED SELF INTERVENTION AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3172818

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention