BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 8702781 · Received June 17, 2019

    Report

    Report Number
    3008382007-2019-02164
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    May 31, 2019
    Report Date
    June 8, 2019
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    UDI-DI
    00353885008402
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH VERIO IQ METER DISPLAYED INACCURATELY HIGH RESULTS COMPARED TO HIS FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE SUBJECT METER WAS READING INACCURATELY BETWEEN 5PM AND 6PM ON (B)(6) 2019, WHEN HE OBTAINED ALLEGED INACCURATE BLOOD GLUCOSE RESULTS OF ¿212 AND 226 MG/DL¿. THE PATIENT CONSIDERED THE READINGS HIGH COMPARED TO HIS FEELINGS/NORMAL RESULTS. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE THE POSSIBILITY OF AN INACCURACY. THE PATIENT MANAGES HIS DIABETES WITH A COMBINATION OF HUMALOG AND HUMULIN INSULIN AND METFORMIN ORAL MEDICATION. HE REPORTED THAT AFTER OBTAINING THE ALLEGED INACCURATE RESULTS, HE WENT FOR A ¿BRISK WALK¿. HE REPORTED THAT 10-15 MINUTES LATER, HE FELT LIKE ¿PASSING OUT¿ AND WAS ¿DRAGGING¿ HIS ¿FEET¿. HE INDICATED THAT HE SAT DOWN AND WAS GIVEN ¿ORANGE JUICE¿ BY HIS WIFE. HE STATED THAT THE PARAMEDICS WERE CONTACTED, AND HE WAS GIVEN A ¿BOTTLE OF SUGAR LIQUID¿ AND SENT TO HOSPITAL. HE INDICATED THAT A BLOOD GLUCOSE RESULT OF ¿48 MG/DL¿ WAS OBTAINED ON THE ER/HOSPITAL METER. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THE TEST STRIPS WERE WITHIN EXPIRY DATE AND HAD BEEN STORED CORRECTLY. THE CCA WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST AND THE RESULT OF ¿152 MG/DL¿ FELL OUTSIDE THE EXPECTED RANGE OF 102-138 MG/DL. 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 REQUIRING MEDICAL INTERVENTION, AFTER OBTAINING HIGH READINGS ON THE METER AND GOING FOR A BRISK WALK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496545 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH 00353885008402

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R