BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO2 METER

    MDR report key: 5989692 · Received September 30, 2016

    Report

    Report Number
    3008382007-2016-50636
    Event Type
    Injury
    Date Received
    September 30, 2016
    Report Date
    September 19, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K131363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE RETURNED TO LIFESCAN THEY WERE FOUND TO HAVE METER SERIAL NUMBER (B)(4)AND TEST STRIP LOT NUMBER 3955690.

    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.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE TEST STRIPS PASSED ALL 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) 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HER ONETOUCH VERIO2 METER READ INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE METER ISSUE BEGAN ON (B)(6) 2016, AT 08:00AM, AND STATED THAT SHE OBTAINED A RESULT OF "250MG/DL" ON THE SUBJECT METER. THERE WAS NO COMPARISON PROVIDED THAT MEETS LFS CRITERIA OF A VALID COMPARISON FOR ACCURACY. THE PATIENT MANAGES HER DIABETES BY SELF-ADJUSTING HER INSULIN DOSES AND ADMINISTERED A DOSE OF NOVORAPID INSULIN IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT "5 MINUTES" AFTER THE ALLEGED ISSUE OCCURRED SHE DEVELOPED A SYMPTOM OF SWEATING AND SELF-TREATED WITH "GLUCOSE AND JUICE". DURING TROUBLESHOOTING THE CCA NOTED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND THE TEST STRIPS HAD NOT EXPIRED OR BEEN STORED INCORRECTLY. PRODUCT WAS REPLACED AND REQUESTED BACK FOR EVALUATION. THIS COMPLAINT IS BEING REPORTED AS THE PATIENT DEVELOPED SYMPTOMS THAT MEET LFS CRITERIA OF A SERIOUS HYPOGLYCEMIC EVENT AFTER THE ALLEGED ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641705 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Life Threatening| R