BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA 2 METER

    MDR report key: 18158168 · Received November 17, 2023

    Report

    Report Number
    3009698388-2023-00033
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    November 5, 2023
    Report Date
    November 17, 2023
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    UDI-DI
    00353885008372
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SIMILAR COMPLAINTS FOR THIS ISSUE WERE TRENDED INCLUDING THE REPORTED METER. IT WAS CONCLUDED THAT THE NUMBER OF COMPLAINTS FOR THE METER DID NOT BREACH THRESHOLDS INDICATIVE OF A SYSTEMIC ISSUE. IN ADDITION, SIMILAR COMPLAINTS FOR THIS ISSUE WERE TRENDED FOR THE TEST STRIP LOT. IT WAS CONCLUDED THAT THE NUMBER OF COMPLAINTS FOR THE LOT DID NOT BREACH THRESHOLDS INDICATIVE OF A SYSTEMIC ISSUE.

    Description of Event or Problem · 0

    ON (B)(6), 2023, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA ALLEGING THAT HIS ONETOUCH ULTRA2 METER DISPLAYED INACCURATELY HIGH RESULTS COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION OF THE INITIAL CALL. THE PATIENT ALLEGED THAT THE SUBJECT METER STARTED DISPLAYING INACCURATE HIGH READINGS ON (B)(6), 2023, IN THE MORNING. THE PATIENT REPORTED THAT HE RECEIVED BLOOD GLUCOSE READINGS OF ¿121, 167, 168 AND 144 MG/DL¿ ON THE SUBJECT METER. HE COMPARED THE READINGS TO HIS WIFE¿S ONETOUCH VERIO FLEX METER THAT GAVE HIM A DIFFERENCE OF 30-35 POINTS LOWER. THE TIME DIFFERENCE BETWEEN READINGS WAS 30 MINUTES OR LESS. THE PATIENT MANAGES HIS DIABETES WITH A COMBINATION OF DIABETES MEDICATION (GALE INSULIN ¿ 25 UNITS, HIGH LIVASONE 44 MG AND FARXIGA 5 MG) AND STATED THAT HE INCREASED HIS INSULIN TO 30 UNITS AT NIGHT ON (B)(6), 2023, IN RESPONSE TO THE ALLEGED ISSUE. THE MORNING AFTER (ON (B)(6), 2023) THE PATIENT ¿COLLAPSED MOMENTARY AND FELT DIZZY¿. THE PATIENT CLAIMED THAT HE SELF-TREATED WITH FOOD AND TOOK A NAP. AFTER TREATMENT THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF ¿97 MG/DL¿ ON ANOTHER DEVICE. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLES AND THAT THE PATIENT WAS FOLLOWING THE CORRECT TESTING PROCEDURE. THE PATIENT PERFORMED A CONTROL SOLUTION TEST AND THE RESULT WAS IN RANGE. THE CCA ESTABLISHED THAT THE TEST STRIP VIAL WAS INTACT, THAT THE TEST STRIPS HAD BEEN STORED PROPERLY, WERE NOT OPEN BEYOND THEIR DISCARD DATE AND HAD NOT EXPIRED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT AFTER TAKING AN INCREASED DOSE OF INSULIN BASED ON ALLEGED INACCURATE HIGH RESULTS OBTAINED WITH THE SUBJECT METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299405 OT ULTRA 2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 5676852 00353885008372

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening