BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2183323 · Received July 28, 2011

    Report

    Report Number
    2939301-2011-06566
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 29, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH AS COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE REPORTER THAT ON (B)(6) 2011 AT AROUND 8:00AM, THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "486 MG/DL" WITH A LIFESCAN METER AND "333MG/DL" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OR LESS 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. THE REPORTER STATED THAT THE PATIENT TAKES INSULIN, NOVALIN R (UNKNOWN DOSAGE), TO MANAGE HER DIABETES. TWELVE HOURS AFTER THE ALLEGED ISSUE BEGAN, THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED SYMPTOMS OF "NAUSEA AND SWEAT" AND IN RESPONSE TO THESE SYMPTOMS, ON (B)(6) 2011 AT NOON, THE PATIENT WENT TO SEE HER DOCTOR WHERE SHE WAS TREATED WITH FOOD AND DRINK AND WAS TESTED WITH THE CLINIC'S METER (UNKNOWN TYPE) AND OBTAINED A READING OF "333MG/DL". ON (B)(6) 2011 AT 8:00AM, IN RESPONSE TO THE ALLEGED ISSUE, THE REPORTER INFORMED THE CCA THAT THE PATIENT INCREASED HER NOVALIN R INTAKE TO 4 UNITS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE CCA ALSO NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND RECEIVED MEDICAL TREATMENT AFTER THE ALLEGED ISSUE OCCURRED.

    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 87 YR Life Threatening