BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 6360002 · Received February 27, 2017

    Report

    Report Number
    3008382007-2017-09976
    Event Type
    Injury
    Date Received
    February 27, 2017
    Date of Event
    February 14, 2017
    Report Date
    February 16, 2017
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH VERIOIQ METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER DEVICE (ACCUCHEK PERFORMA). THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED BY THE CSR DURING A FOLLOW-UP CALL WITH THE PATIENT ON (B)(6) 2017. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN AT 4:15 P.M., ON (B)(6) 2017. THE PATIENT CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿360 MG/DL¿ WITH THE SUBJECT METER AND ¿289 MG/DL¿ WITH THE OTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. METER TO OTHER METER COMPARISONS DO NOT REASONABLY SUGGEST THAT A MALFUNCTION HAS OCCURRED. THERE CAN BE NO PRESUMPTION AS TO WHICH METER¿S READING IS ERRONEOUS AS THE COMPARISON IS NOT MADE TO A CALIBRATED REFERENCE METHOD. THE PATIENT MANAGES HER DIABETES WITH INSULIN (NO ADJUSTMENTS) AND IT IS NOT CLEAR WHAT CHANGES, IF ANY, THE PATIENT MADE TO HER USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT REPORTED THAT APPROXIMATELY 30 MINUTES AFTER THE ALLEGED ISSUE BEGAN, SHE BECAME ¿VERY HYPOGLYCEMIC¿ AND DURING THE FOLLOW-UP CALL WITH THE CSR, SHE ADVISED THAT SHE HAD DEVELOPED SYMPTOMS OF ¿SWEATING, BLURRED VISION¿ AND THAT HER ¿HEART BEAT FAST.¿ THE PATIENT ADVISED THAT SHE SELF-TREATED HER SYMPTOMS BY EATING SOME FOOD. THE PATIENT DENIED TESTING HER BLOOD GLUCOSE ON ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER AND THAT AN APPROVED SAMPLE SITE WAS USED TO OBTAIN THE RESULTS. THE CSR ALSO WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST AND THE RESULT OBTAINED FELL WITHIN THE EXPECTED RANGE OF 102-138 MG/DL. THE SUBJECT PRODUCTS WERE REQUESTED BACK FOR INVESTIGATION AND REPLACEMENTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS AND/OR SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145084 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4113481

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R