BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 5535089 · Received March 30, 2016

    Report

    Report Number
    2939301-2016-15338
    Event Type
    Injury
    Date Received
    March 30, 2016
    Date of Event
    February 20, 2016
    Report Date
    March 23, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 MARCH 23, 2016, THE LAY USER/PATIENT CONTACTED LIFESCAN USA ALLEGING THAT HIS ONETOUCH ULTRA2 METER READ INACCURATELY LOW WHEN TESTED WITH CONTROL SOLUTION. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED PRODUCT ISSUE BEGAN ON (B)(6) 2016 (TIME NOT PROVIDED). THE PATIENT STATED THAT HE OBTAINED THE RESULTS OF "110, 113 AND 109 MG/DL" USING THE SUBJECT METER COMPARED TO THE CONTROL SOLUTION RANGE OF "111-149 MG/DL". THE PATIENT MANAGES HIS DIABETES USING A COMBINATION OF INSULIN, METFORMIN AND JANUVIA DIABETES MEDICATIONS. THE PATIENT WAS UNABLE/UNWILLING TO STATE IF HE MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. THE PATIENT CLAIMED THAT HIS GLUCOSE "WENT UP 200 MG/DL" AFTER THE ALLEGED PRODUCT ISSUE BEGAN (DATE/TIME NOT PROVIDED). THE PATIENT STATED THAT HE VISITED HIS DOCTOR'S OFFICE ON (B)(6) 2016 WHERE HE RECEIVED TREATMENT OF INSULIN. THE PATIENT STATED THAT HIS BLOOD GLUCOSE WAS TESTED USING ANOTHER DEVICE ON (B)(6) 2016, AND THE RESULTS OBTAINED WERE "83, 124 AND 105 MG/DL". THE PATIENT ALSO TESTED HIS BLOOD GLUCOSE USING THE SUBJECT METER (DATE/TIME NOT PROVIDED) AND THE RESULTS OBTAINED WERE "123, 77 AND 157 MG/DL". AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE INCORRECT CONTROL SOLUTION WAS BEING USED AND THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE RECEIVED HCP TREATMENT OF INSULIN. THIS TREATMENT DOES MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191066 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3881536

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R