BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2123694 · Received June 14, 2011

    Report

    Report Number
    2939301-2011-04798
    Event Type
    Injury
    Date Received
    June 14, 2011
    Report Date
    May 30, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    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 K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HER EXPECTED RESULTS. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION. THE MSS WAS ADVISED THE PATIENT TESTS HER BLOOD GLUCOSE 4X DAILY. THE PATIENT MANAGES HER DIABETES WITH NOVOLOG INSULIN (20 UNITS BEFORE MEALS AND 3-4 UNITS AT NIGHT IF BLOOD GLUCOSE IS ELEVATED) AND LEVEMIR INSULIN (52 UNITS IN THE MORNING AND 54 UNITS IN THE EVENING). THE ALLEGED ISSUE BEGAN ABOUT 2 MONTHS AGO PRIOR TO CONTACTING LFS. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "350 AND 179 MG/DL" WITH THE SUBJECT METER. THE PATIENT STATED HER BLOOD GLUCOSE USUALLY READS "90-150 MG/DL." THE PATIENT STATED SHE INCREASED HER USUAL DOSE OF INSULIN. AFTERWARDS, THE PATIENT CLAIMED SHE FELT LOW BLOOD GLUCOSE SYMPTOMS OF SWEATING, HEADACHE AND HAD A "FUNNY FEELING IN HER STOMACH." THE PATIENT TOOK FOOD AND/ OR DRANK A BEVERAGE AS TREATMENT AND FELT BETTER AFTER. AT THE TIME OF TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R