BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 5469559 · Received March 1, 2016

    Report

    Report Number
    2939301-2016-09622
    Event Type
    Injury
    Date Received
    March 1, 2016
    Date of Event
    February 23, 2016
    Report Date
    February 24, 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
    DE, 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 (B)(6) 2016, THE REPORTER CONTACTED LIFESCAN USA ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER READ INACCURATELY HIGH. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED PRODUCT ISSUE BEGAN ON (B)(6) 2016 (TIME NOT PROVIDED). THE REPORTER STATED THAT THE PATIENT OBTAINED THE RESULTS OF "215, 203, 213, 233, 184 AND 227 MG/DL" USING THE SUBJECT METER COMPARED TO FEELINGS/NORMAL RESULTS. THE PATIENT MANAGES HIS DIABETES WITH A COMBINATION OF METFORMIN (1 G), ONGLYZA (5 MG), HUMALOG AND LEVEMIR (INSULIN DOSE DEPENDS ON RESULTS OBTAINED). THE REPORTER STATED THAT THE PATIENT FOLLOWED HIS USUAL DOSE OF 22IU OF LEVEMIR INSULIN (INCLUDING SLIDING SCALE) BETWEEN 9:30PM-10:00PM. THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED THE SYMPTOMS OF "HIGH HEART RATE, SHAKINESS AND SWEATING" ON (B)(6) 2016 AT AROUND 1:30PM; HOWEVER THE REPORTER DENIED THAT THE PATIENT RECEIVED ANY TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A WALK-THROUGH TEST AND THE TEST STRIPS HAD NOT EXPIRED, BEEN OPEN FOR LONGER THAN THE DISCARD DATE OR STORED IMPROPERLY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED THE SYMPTOMS OF "HIGH HEART RATE, SHAKINESS AND SWEATING" AFTER THE ALLEGED PRODUCT ISSUE BEGAN. THESE SYMPTOMS DO MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125949 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3901159

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening