BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO2 METER

    MDR report key: 6309887 · Received February 8, 2017

    Report

    Report Number
    3008382007-2017-06445
    Event Type
    Injury
    Date Received
    February 8, 2017
    Report Date
    January 30, 2017
    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
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT¿S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE PRODUCT PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT¿S METER HAS 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. 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) 2017, THE LAY-USER/PATIENT¿S SPOUSE CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER WAS READING INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2016. THE REPORTER CLAIMED THE PATIENT OBTAINED ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿459, 214, 281,245, 240, 201, 250, 308, 206, 290 MG/DL¿ WITH THE SUBJECT METER ON UNSPECIFIED DATES. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE THE POSSIBILITY OF INACCURACY. THE PATIENT MANAGES HIS DIABETES WITH SELF-ADJUSTED INSULIN. IT WAS NOT REPORTED IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED ISSUE. THE REPORTER CLAIMED THAT 5 WEEKS AFTER THE ALLEGED ISSUE STARTED THE PATIENT WAS ¿SICK WITH THE FLU, THREW UP, DROOLING, SLEEPY AND ALMOST FELL DOWN¿. THE REPORTER CLAIMED THE EMERGENCY MEDICAL SERVICES (EMS) WERE CONTACTED FOR ASSISTANCE ON (B)(6) 2017 AT 5:45 PM AND STATED THE PATIENT WAS TREATED BY EMS WITH FOOD/DRINK AND IV FLUIDS BEFORE BEING TAKEN TO HOSPITAL. THE REPORTER CLAIMED THE PATIENT¿S BLOOD GLUCOSE WAS TESTED ON THE EMS DEVICE AT 6:00 PM AND A RESULT OF ¿31 MG/DL¿ WAS OBTAINED. THE REPORTER INFORMED THE CSR THAT THE PATIENT DID NOT PERFORM A BLOOD GLUCOSE TEST WITH THE SUBJECT METER PRIOR TO EMS BEING CONTACTED. DURING TROUBLESHOOTING, THE CSR CONFIRMED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSR NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO TEST THE SUBJECT METER. THE PRODUCTS INVOLVED IN THE COMPLAINT WERE REQUESTED BACK FOR INVESTIGATION AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS THAT MEET LFS¿ CRITERIA FOR A SERIOUS INJURY REPORTABLE ADVERSE EVENT AFTER THE ALLEGED INACCURACY ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94792 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4054768 00353885008730

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R