BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO FLEX METER

    MDR report key: 8054253 · Received November 9, 2018

    Report

    Report Number
    3008382007-2018-03107
    Event Type
    Injury
    Date Received
    November 9, 2018
    Report Date
    October 25, 2018
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    UDI-DI
    00353885010986
    PMA / PMN Number
    K150214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HER ONETOUCH VERIO FLEX METER WAS READING INACCURATELY ERRATIC AND INACCURATELY HIGH COMPARED TO HER FEELINGS AND USUAL RESULTS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION AS WELL AS ADDITIONAL INFORMATION OBTAINED WHEN THE MEDICAL SURVEILLANCE SPECIALIST REVIEWED THE CALL. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN ON THE MORNING OF (B)(6) 2018. THE PATIENT CLAIMED THAT SHE WAS GETTING ERRATIC READINGS AS ONE OF HER VIALS OF STRIPS WAS READING HIGHER THAN THE OTHER. THE CUSTOMER CLAIMED TO OBTAIN READINGS OF ¿197, 211, 183, 205, 197, 166, 396, 178, 209, 261 AND 231 MG/DL¿ WITH HER OLD VIAL OF TEST STRIPS WHICH SHE BELIEVED TO BE INACCURATELY HIGH COMPARED TO HER NORMAL RANGE OF ¿90-120 MG/DL¿. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LIFESCAN TO DETERMINE AN INACCURACY. THE PATIENT THEN COMPARED THESE READING TO HER NEW VIAL OF STRIPS WHICH GAVE READINGS OF ¿100, 88, 76, 73, 87, 63, 98, 70, 65, 75, 73, 56 AND 106 MG/DL¿. THE RESULTS REPORTED WERE OBTAINED OVER A 3-WEEK PERIOD. LIFESCAN CANNOT CONFIRM AN INACCURACY FROM THE DATA PROVIDED. THE PATIENT REPORTED THAT SHE MANAGES HER DIABETES WITH METFORMIN. THE PATIENT CLAIMED THAT 15 DAYS AFTER THE ALLEGED INACCURACIES BEGAN, ON (B)(6) 2018, SHE DEVELOPED SYMPTOMS OF ¿GOT REALLY SICK, SWEATING, FELT REALLY BAD, HAD COLD CHILLS AND FELT LIKE HER BLOOD SUGAR WAS LOW¿. THE PATIENT CLAIMED THAT SHE TESTED HER BLOOD GLUCOSE AND OBTAINED A RESULT OF ¿297 MG/DL¿ SO CALLED HER DOCTOR AND WAS ADVISED TO ¿DRINK A LOT OF WATER AND TO KEEP WALKING AROUND¿ IN RESPONSE TO THE HIGH READING. THE PATIENT THEN CLAIMED THAT 3-4 HOURS LATER SHE OBTAINED A RESULT OF ¿ABOUT 50 MG/DL¿ WHICH CORRESPONDED TO HOW SHE FELT. THE PATIENT REPORTED THAT SHE CALLED HER DOCTOR AGAIN AND WAS ADVISED TO DRINK JUICE AS TREATMENT. THERE WAS NO REPORT OF ANY FURTHER FORM OF TREATMENT OR MEDICAL INTERVENTION RECEIVED AS A RESULT OF THE ALLEGED INACCURACY ISSUE. AT THE TIME OF TROUBLESHOOTING THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSR NOTED THAT AN APPROVED SAMPLE SITE WAS USED FOR TESTING AND THAT THE TEST STRIPS WERE STORED CORRECTLY, WITHIN EXPIRY DATE AND THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE CSR NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. 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 OBTAINING ALLEGED INACCURATE HIGH READINGS WITH ONE OF HER VIALS OF TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895656 OT VERIO FLEX METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH 4269427 00353885010986

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R