BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO SYNC METER

    MDR report key: 3852737 · Received June 6, 2014

    Report

    Report Number
    2939301-2014-13616
    Event Type
    Injury
    Date Received
    June 6, 2014
    Report Date
    May 29, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K120708
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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) 2014, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH VERIO SYNC METER DISPLAYED AN ¿ERROR 4¿ MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2014. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS USUAL MANAGEMENT ROUTINE. ABOUT 1-2 WEEKS AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED HE FELT SYMPTOMS OF BLURRED VISION, FREQUENT URINATION AND FATIGUE. NO TREATMENT WAS SPECIFIED AT THAT TIME. ON (B)(6) 2014, THE PATIENT REPORTEDLY VISITED HER PHYSICIAN¿S OFFICE. THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿256 MG/DL¿ WITH THE PHYSICIAN/ CLINIC METER. THE PATIENT WAS PROVIDED A ¿NEW PRESCRIPTION;¿ HOWEVER, NO ADDITIONAL TREATMENT WAS SPECIFIED. THE PATIENT DID NOT HAVE HIS TESTING SUPPLIES TO WALK THROUGH TROUBLESHOOTING AND RESOLVE THE REPORTED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331972 OT VERIO SYNC METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3481970

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening