BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO2 METER

    MDR report key: 7528873 · Received May 21, 2018

    Report

    Report Number
    3008382007-2018-01457
    Event Type
    Injury
    Date Received
    May 21, 2018
    Date of Event
    May 11, 2018
    Report Date
    May 12, 2018
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008730
    PMA / PMN Number
    K131363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH VERIO 2 METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THAT THE ISSUE BEGAN ON (B)(6) 2018 (EXACT TIME NOT PROVIDED) WHEN SHE ALLEGED OBTAINING BLOOD GLUCOSE RESULTS OF ¿75, 182, 122, 103 AND 113MG/DL¿ USING THE SUBJECT DEVICE WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT STATED THAT SHE DOES NOT TAKE ANY DIABETES MEDICATIONS AND MANAGES HER DIABETES USING DIET/EXERCISE AND DENIED MAKING ANY CHANGES TO HER USUAL MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED EXPERIENCING SYMPTOMS OF ¿MASSIVE HEADACHE, BLURRY VISION, SHAKY AND VERTIGO¿ APPROXIMATELY 30 MINUTES BEFORE THE ALLEGED ISSUE BEGAN. THE PATIENT STATED THAT SHE CALLED HER CAREGIVER ON (B)(6) AT 6AM, WHO VISITED HER, MEASURED HER BLOOD GLUCOSE LEVEL USING ANOTHER DEVICE (BRAND AND RESULT NOT KNOWN) AND LET HER DRINK SOME MILK IN RESPONSE TO THE REPORTED EVENT. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND AN APPROVED SAMPLE SITE WAS BEING USED. THE CSR NOT THAT THE PATIENT¿S TESTING PROCEDURE WAS INCORRECT AS THE TEST STRIPS BEING USED WERE TAKEN FROM DIFFERENT VIALS, THEREBY INVALIDATING THE ACCURACY COMPARISON. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT WHILE USING THE PRODUCT. ALTHOUGH THE PATIENT¿S SYMPTOMS OCCURRED PRIOR TO THEM OBTAINING THE ALLEGED INACCURATELY ERRATIC RESULTS, THE ALLEGED METER ISSUE COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373247 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4369260 00353885008730

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R