BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2770982 · Received October 3, 2012

    Report

    Report Number
    2939301-2012-11382
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 14, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND.

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED BUT NOT YET EVALUATED BY LIFESCAN PRODUCT ANALYSIS. LFS WILL EVALUATE IT AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS/ NORMAL BLOOD GLUCOSE RESULTS. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2012 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT TESTS HER BLOOD GLUCOSE 4X DAILY. THE PATIENT MANAGES HER DIABETES WITH NOVOLOG INSULIN (7 UNITS LUNCH AND BEFORE BED/ 8 UNITS DINNER) AND LEVEMIR INSULIN (10 UNITS MORNING/ 12 UNITS BEFORE BED). THE ALLEGED ISSUE BEGAN ON SEPTEMBER 14, 2012 AROUND 830AM-9AM. THE PATIENT REPORTED OBTAINING A "HIGH GLUCOSE" (OVER 600 MG/DL) RESULT WITH THE SUBJECT METER BEFORE EATING BREAKFAST. THE PATIENT DENIED MAKING CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. ABOUT 1215PM THAT SAME DAY, PRIOR TO GOING TO A MAMMOGRAM APPOINTMENT, THE PATIENT CLAIMS SHE FELT SYMPTOMS OF NERVOUS, SHAKY, UNEASY AND SWEATY. THE PATIENT'S REPORTED SYMPTOMS PROMPTED HER TO TEST AND OBTAINED A BLOOD GLUCOSE RESULT OF "43 MG/DL" WITH THE SUBJECT METER. THE PATIENT ATE JELLY CANDY AND FELT BETTER SHORTLY AFTER. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3298240

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening| R