BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2220765 · Received August 23, 2011

    Report

    Report Number
    2939301-2011-07912
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE NOT BEEN RETURNED TO LIFESCAN FOR PRODUCT ANALYSIS. THE RETAIN TEST STRIPS WERE TESTED AND THEY PASSED TESTING WITH NO FAULTS FOUND. THE 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS READING INACCURATE HIGH AS COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT ON (B)(6) 2011 AT 2:00 PM, SHE OBTAINED THE ALLEGED HIGH READING OF "60MG/DL" WITH THE SUBJECT METER. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION (UNKNOWN TYPE AND DOSAGE), DIET AND EXERCISE AND TOOK HER USUAL DOSE OF MEDICATION IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. SHORTLY AFTER THE REPORTED ISSUE BEGAN, THE PATIENT CLAIMED TO HAVE BECOME "UNRESPONSIVE" AND BY 2:15 PM, EMS WAS CALLED IN AND THE PATIENT WAS TESTED ON THEIR METER WHERE THE PATIENT OBTAINED A READING OF "30MG/DL." THE TESTS ON BOTH THE SUBJECT METER AND ON THE EMS DEVICE WERE PERFORMED WITHIN 30 MINUTES OR LESS OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS WAS WITHIN THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. IMMEDIATELY AFTER, THE PATIENT REPORTED BEING ADMINISTERED WITH A GLUCOSE GEL IV. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT AN APPROVED SAMPLE SITE WAS USED FOR TESTING BUT WAS UNABLE TO VERIFY IF THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT DEVELOPED SYMPTOMS OF A SERIOUS INJURY AND RECEIVED MEDICAL TREATMENT AFTER THE ALLEGED PRODUCT ISSUE OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening