BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO2 METER

    MDR report key: 6299444 · Received February 3, 2017

    Report

    Report Number
    3008382007-2017-05777
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    January 27, 2017
    Report Date
    January 28, 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
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS 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, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT¿S ONETOUCH VERIO2 METER WAS READING INACCURATELY HIGH COMPARED TO THE PATIENT¿S FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER ADVISED THAT THE ALLEGED INACCURACY ISSUE BEGAN AT 6:45 P.M., ON (B)(6) 2017. THE REPORTER CLAIMED THAT THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF ¿208, 210, 313, 168, 183 AND 269 MG/DL¿ WITH THE SUBJECT METER WHICH THE PATIENT FELT WERE HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL RESULTS. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE PATIENT MANAGES HIS DIABETES WITH A COMBINATION OF MEDICATIONS (LANTUS, 20 UNITS IN THE EVENINGS AND NOVOLOG BASED ON A SLIDING SCALE) AND THE REPORTER STATED THAT IN RESPONSE TO THE ALLEGED INACCURATELY HIGH READING OF ¿313 MG/DL¿, THE PATIENT ADMINISTERED HIS USUAL DOSE OF LANTUS (20 UNITS) ALONG WITH AN ADDITIONAL 10 UNITS OF NOVOLOG. THE REPORTER ADVISED THAT APPROXIMATELY 6 HOURS AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT AWOKE AT 12:50 A.M., ON (B)(6) 2017, HAVING DEVELOPED SYMPTOMS OF FEELING ¿SHAKY, SWEATY AND DISORIENTED.¿ AT THIS TIME, THE REPORTER STATED THAT SHE TESTED THE PATIENT¿S BLOOD GLUCOSE WITH THE SUBJECT DEVICE AND CLAIMED OBTAINING A RESULT OF ¿56 MG/DL¿. THE REPORTER ADVISED THAT AT 1 A.M., SHE GAVE THE PATIENT EGGS AND TOAST WITH JELLY TO ¿BRING HIS SUGAR BACK UP.¿ THE REPORTER DENIED THAT THE PATIENT HAD HIS BLOOD GLUCOSE TESTED ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CSR CONFIRMED THAT THE TEST STRIPS HAD BEEN STORED PROPERLY, WERE NOT OPEN BEYOND THEIR DISCARD DATE AND HAD NOT EXPIRED. THE CSR WALKED THE REPORTER THROUGH A CONTROL SOLUTION TEST; HOWEVER, THE REPORTER WAS UNABLE AND/OR UNWILLING TO CONFIRM IF THE RESULT OBTAINED WAS WITHIN THE SPECIFIED CONTROL SOLUTION RANGE. THE SUBJECT PRODUCTS WERE REQUESTED BACK FOR INVESTIGATION AND REPLACEMENTS WERE SENT TO THE PATIENT. 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
    84099 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4103042 00353885008730

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R