BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO IQ METER

    MDR report key: 6072029 · Received November 2, 2016

    Report

    Report Number
    3008382007-2016-56609
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    October 27, 2016
    Report Date
    October 28, 2016
    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
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HIS ONETOUCH VERIOIQ METER DISPLAYED INACCURATELY ERRATIC RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT CLAIMED THAT THE SUBJECT METER STARTED READING INACCURATELY AT 00:13AM ON (B)(6) 2016, WHEN HE OBTAINED ALLEGED INACCURATELY ERRATIC BLOOD GLUCOSE RESULTS OF "221, 209, 182, 173 AND 186 MG/DL" WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THE REPORTED RESULTS MEETS LFS' CRITERIA FOR PRECISION. THE PATIENT MANAGES HIS DIABETES WITH INSULIN WHICH HE SELF-ADJUSTS. HE REPORTED THAT AT 00:15AM ON (B)(6) 2016, HE ADMINISTERED AN INCREASED DOSE OF 107 UNITS OF NOVORAPID INSULIN AND WENT TO SLEEP. HE REPORTED THAT ABOUT 3 HOURS LATER, AT 3AM ON (B)(6) 2016, HE WOKE UP WITH SYMPTOMS OF "SWEATING AND FELT DIZZY". HE INDICATED THAT HE SELF-TREATED HIS SYMPTOMS BY CONSUMING A "BOTTLE OF COKE" AND A SHORT TIME LATER "FELT BETTER". HE DENIED USING ANY OTHER DEVICE TO CHECK HIS BLOOD GLUCOSE LEVELS. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THE PATIENT'S BLOOD SAMPLES HAD BEEN TAKEN FROM THE SAME APPROVED SAMPLE SITE. THE PATIENT'S TEST STRIPS ARE BEING RETURNED FOR INVESTIGATION AND REPLACEMENT TEST STRIP WERE SENT TO THE PATIENT. THE PATIENT WANTED TO KEEP THE SUBJECT METER. 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
    724079 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3912199

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R