BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA 2 METER

    MDR report key: 9942862 · Received April 9, 2020

    Report

    Report Number
    3008382007-2020-03892
    Event Type
    Injury
    Date Received
    April 9, 2020
    Date of Event
    April 5, 2020
    Report Date
    April 7, 2020
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    UDI-DI
    00353885008372
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON APRIL 7, 2020, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE AGENT (CSA) DOCUMENTATION. THE PATIENT STATED THAT ON (B)(6) 2020 AT 4:00 AM, SHE WOKE UP FEELING ¿WEAK AND COULDN¿T MOVE.¿ IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED HER HUSBAND TESTED HER BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED A RESULT OF ¿200 MG/DL." THE EMERGENCY MEDICAL SERVICES (EMS) WERE REPORTEDLY CONTACTED FOR ASSISTANCE AND WHEN THEY ARRIVED, HER BLOOD GLUCOSE WAS MEASURED AT ¿30 MG/DL¿ ON THE EMS METER. THE TESTS WERE PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT CLAIMED THAT EMS TREATED HER WITH IV GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CSA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSA NOTED THAT AN APPROVED SAMPLE SITE WAS USED FOR TESTING AND THAT THE CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CSA CONFIRMED THE TEST STRIP VIAL WAS INTACT AND THAT THE TEST STRIPS HAD BEEN STORED CORRECTLY AND WERE NOT EXPIRED OR OPENED PAST THEIR DISCARD DATE. THE CSA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FOR AN ACUTE LOW BLOOD GLUCOSE EXCURSION AFTER OBTAINING AN ALLEGED INACCURATE HIGH RESULT WITH THE SUBJECT METER. THE SUBJECT METER COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410911 OT ULTRA 2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH 021-105 4544340 00353885008372

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R