BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2223781 · Received August 25, 2011

    Report

    Report Number
    2939301-2011-08133
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON AUGUST 18, 2011WITH 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. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE PATIENT STATED THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2011. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "171 MG/DL AND 99MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=20% AND/ OR <=20 MG/DL. THE PATIENT REPORTEDLY MANAGES HIS DIABETES WITH LANTUS INSULIN (30 UNITS) AND HUMALOG INSULIN BASED ON A SLIDING SCALE. THE PATIENT STATED HE CONTINUED WITH HIS USUAL DIABETES MANAGEMENT ROUTINE AFTER RECEIVING THE ALLEGED INACCURATE RESULTS. THE PATIENT CLAIMED THAT ONE DAY LATER, HE BEGAN TO EXPERIENCE SYMPTOMS OF "JITTERS AND SHAKES" AT AN UNSPECIFIED TIME. IT WOULD HAVE BEEN HELPFUL TO KNOW IF THE PATIENT CONTINUED TO USE THE SUBJECT METER AFTER THE ALLEGED ISSUE BEGAN AND THE RESULTS IF OBTAINED. THE PATIENT REPORTED THAT HE SELF-TREATED HIS SYMPTOMS WITH GLUCOSE TABLETS AT AN UNSPECIFIED TIME. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE UNIT OF MEASURE WAS SET CORRECTLY. THE TEST STRIPS WERE IN GOOD CONDITION AND THE BLOOD SAMPLE WAS TAKEN FROM THE SAME, APPROVED SAMPLE SITE. THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION TO CHECK THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA 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. 3118963

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| R