BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO FLEX METER

    MDR report key: 13502348 · Received February 9, 2022

    Report

    Report Number
    3008382007-2022-04290
    Event Type
    Injury
    Date Received
    February 9, 2022
    Report Date
    February 9, 2022
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    UDI-DI
    00353885010986
    PMA / PMN Number
    K150214
    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 FEBRUARY 06, 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) UNITED STATES, ALLEGING THAT THEIR ONETOUCH VERIO FLEX METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THEY FIRST BECAME AWARE OF THE ALLEGED METER INACCURACY ON THE MORNING OF (B)(6) 2021, AROUND 8:30 TO 9:30 AM, JUST AFTER THEY WERE DISCHARGED FROM HOSPITAL. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿110, 142, 142, 129 AND 116 MG/DL¿ WITH THE SUBJECT METER, PERFORMED MORE THAN 20 MINUTES APART. THE PATIENT STATED THAT THEY MANAGE THEIR DIABETES WITH A COMBINATION OF MEDICATION (METFORMIN TWICE DAILY; TRULICITY ONCE WEEKLY) AND DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT REPORTED DEVELOPING SYMPTOMS OF FEELING ¿SHAKY, TREMORS AND CONFUSED A LITTLE BIT¿ AROUND (B)(6) 2022 (THEY WERE UNABLE TO RECALL THE EXACT DATE AND TIME). IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED THEY ATE SMALL PIECES OF FRUIT. THE PATIENT REPORTED THAT THEIR BLOOD GLUCOSE MEASURED ¿111 MG/DL¿ ON ANOTHER DEVICE AFTER TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SAME APPROVED SAMPLE SITE WAS USED FOR TESTING. 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 THE ALLEGED INACCURACY ISSUE BEGAN. 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
    895549 OT VERIO FLEX METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH 023-271 4782341 00353885010986

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening