BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2233863 · Received September 4, 2011

    Report

    Report Number
    2939301-2011-08521
    Event Type
    Injury
    Date Received
    September 4, 2011
    Date of Event
    August 27, 2011
    Report Date
    August 27, 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 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH AS COMPARED TO HIS FEELINGS/NORMAL RESULT(S). 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 7:30AM, HE OBTAINED ALLEGED HIGH READINGS 'OVER 300MG/DL'. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH COMBINATION OF TWO TYPES OF INSULIN (UNKNOWN TYPES), ONE ON A SLIDING SCALE AND THE OTHER 15UNITS IN THE MORNING AND 25UNITS AT NOON. BY 8:00AM ON THE SAME DAY, THE PATIENT REPORTED INCREASING HIS INSULIN INTAKE TO 17UNITS AND HALF AN HOUR LATER, CLAIMED TO HAVE DEVELOPED SYMPTOMS OF BEING 'INCOHERENT'. ON (B)(6) 2011 AT 7:30PM, THE CCA WAS INFORMED BY THE PATIENT THAT HE CALLED EMS WHO TESTED HIM ON THEIR METER (UNKNOWN TYPE) AND OBTAINED A READING OF '50MG/DL' AND FIFTEEN MINUTES LATER, ADMINISTERED HIM WITH GLUCAGON. SHORTLY AFTER, THE PATIENT WAS TESTED AGAIN AND REPORTED OBTAINING A READING OF '132MG/DL'. 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 WAS USING EXPIRED TEST STRIPS. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE ALTHOUGH THE PATIENT DID NOT SUFFER SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY, THE PATIENT RECEIVED MEDICAL TREATMENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    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 31 YR Life Threatening| R