BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO2 METER

    MDR report key: 6536294 · Received May 2, 2017

    Report

    Report Number
    3008382007-2017-20386
    Event Type
    Injury
    Date Received
    May 2, 2017
    Report Date
    April 25, 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
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    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 TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IN ADDITION, LIFESCAN CONDUCTED AN EVALUATION OF THE TEST STRIP LOT AND CONCLUDED THAT THIS LOT DID NOT BREACH THE THRESHOLDS SET FOR ESCALATION AND NO SYSTEMIC ISSUE WAS OBSERVED. ANALYSIS WAS NOT POSSIBLE FOR THE RETURNED METER DUE TO UNKNOWN STORAGE AND HANDLING PREVENTING THE ALLEGATION BEING PHYSICALLY INVESTIGATED. 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 CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH VERIO2 METER WAS READING INACCURATELY WHEN TESTING WITH CONTROL SOLUTION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED INACCURACY ISSUE BEGAN ¿A FEW WEEKS AGO¿ WHEN A READING OF 137MG/DL WAS OBTAINED WHEN CHECKING THE SUBJECT DEVICE WITH CONTROL SOLUTION. THE PATIENT STATED THAT SHE DOES NOT TAKE ANY MEDICATIONS TO MANAGE HER DIABETES AND REPORTEDLY CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE AFTER THE REPORTED ISSUE BEGAN. THE PATIENT STATED THAT SHE EXPERIENCED SYMPTOMS OF ¿BLURRED VISION, SHAKY AND SWEATING¿ RIGHT AWAY AFTER THE ALLEGED ISSUE BEGAN. THE PATIENT DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION IN RESPONSE TO THE REPORTED EVENT. AT THE TIME OF TROUBLESHOOTING, THE CSR CONFIRMED THAT THE METER WAS SET WITH THE CORRECT UNIT OF MEASURE AND THE CORRECT CONTROL SOLUTION WAS BEING USED. THE CSR NOTED THAT THE RESULT FELL WITHIN THE SPECIFIED CONTROL RANGE OF ¿102 -138 MG/DL¿ FOR TEST STRIP LOT # 4169839. THE CSR REQUESTED THE PRODUCTS BACK FOR INVESTIGATION AND REPLACEMENT PRODUCTS 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
    318801 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4169839 00353885008730

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening