BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2221349 · Received August 24, 2011

    Report

    Report Number
    2939301-2011-07976
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (09/20/2011)-DEVICE EVALUATION: THE METER, TEST STRIPS, AND CONTROL SOLUTION INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(6), 2011 THE METER AND TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND. ON (B)(6), 2011 THE CONTROL SOLUTION WAS TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. A SECONDARY ISSUE WAS NOTED, THE CONTROL SOLUTION WAS FOUND TO HAVE HIGH GLUCOSE CONTENT. 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 K021819.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING FAILED CONTROL SOLUTION TESTS WITH HER ONE TOUCH ULTRASMART 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 AFTER SHE DROPPED HER METER ON (B)(6) 2011, AT 2:25 PM. SHE RAN SEVERAL CONTROL TESTS TO VERIFY THE SYSTEM, AND OBTAINED RESULTS OF "97, 101, 100, 99 AND 100 MG/DL" ON THE SUBJECT METER, WHICH ALL FAILED OUTSIDE THE PRINTED TEST STRIP NORMAL RANGE OF "106-141 MG/DL." SINCE THE CONTROL SOLUTION TESTS DID NOT PASS, SHE DID NOT USE THE METER TO CHECK HER BLOOD GLUCOSE. THE PATIENT STATES THAT SHE MANAGES HER DIABETES WITH INSULIN (PUMP THERAPY) AND IT IS UNCLEAR IF SHE MADE ANY CHANGES TO HER TREATMENT DUE TO THE ALLEGED ISSUE. SHE CLAIMED 3 HOURS AFTER THE ALLEGED ISSUE STARTED, SHE DEVELOPED "LOW SYMPTOMS." MSS WAS UNABLE TO CONFIRM WHAT TYPE OF SYMPTOM THE PATIENT WAS EXPERIENCING. THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT DUE TO HER SYMPTOMS. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE CORRECT UNIT OF MEASURE SET IN THE METER, CORRECT CONTROL SOLUTION AND CORRECT UNEXPIRED TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED "LOW SYMPTOMS" SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3144678

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening