BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO REFLECT METER

    MDR report key: 18674357 · Received February 9, 2024

    Report

    Report Number
    3008382007-2024-00011
    Event Type
    Injury
    Date Received
    February 9, 2024
    Date of Event
    January 12, 2024
    Report Date
    February 9, 2024
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    PMA / PMN Number
    K193475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. SIMILAR COMPLAINTS FOR THIS ISSUE WERE ALSO 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), 2024, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH VERIO REFLECT METER WAS READING INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL RESULTS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN AT AROUND 8 A.M., ON (B)(6), 2024. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE RESULTS OF ¿147, 150, 139, 131 AND 125 MG/DL¿ WITH THE SUBJECT DEVICE WHICH THEY FELT WERE INACCURATELY HIGH COMPARED TO THEIR FEELING AND/OR NORMAL READINGS. THE PATIENT MANAGES THEIR DIABETES WITH NON-INSULIN INJECTIONS (OZEMPIC, UNSPECIFIED DOSE) AND DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT AN UNSPECIFIED TIME AFTER OBTAINING THE ALLEGED INACCURATELY HIGH BLOOD GLUCOSE READINGS, THEY DEVELOPED ¿SHAKINESS¿. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT AS A RESULT OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE DEVICE AT THE TIME OF TESTING. 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. THE CCA ALSO NOTED THAT AT THE TIME OF THE CALL, THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT SYSTEM. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT FOR AN ACUTE LOW BLOOD GLUCOSE EXCURSION AFTER OBTAINING ALLEGED INACCURATELY HIGH BLOOD GLUCOSE READINGS ON THE SUBJECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283510 OT VERIO REFLECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH 5686287

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Life Threatening