BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 5777836 · Received July 8, 2016

    Report

    Report Number
    3008382007-2016-34616
    Event Type
    Injury
    Date Received
    July 8, 2016
    Report Date
    June 28, 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
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS METER AND TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS 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.

    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 LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT ON (B)(6) 2016 AT 09:00AM SHE OBTAINED RESULTS OF "111, 167 AND 144 MG/DL" ON THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT DOES NOT TAKE ANY MEDICATION TO MANAGE HER DIABETES AND CONTINUED TO FOLLOW HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. THE PATIENT REPORTED THAT ONE HOUR AFTER THE ALLEGED ISSUE OCCURRED SHE DEVELOPED A SYMPTOM OF "SHAKY" AND THAT ON (B)(6) 2016 SHE SELF-TREATED WITH FOOD OR DRINK. DURING TROUBLESHOOTING THE CCA NOTED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE AND AN APPROVED SAMPLE SITE WAS USED. IT WAS NOTED THAT THE TEST STRIPS HAD BEEN INCORRECTLY STORED OR HANDLED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT THIS COMPLAINT IS BEING REPORTED AS THE PATIENT SUFFERED A SYMPTOM SUGGESTIVE OF A SERIOUS HYPOGLYCEMIC EVENT AFTER THE ALLEGED ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433302 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3820298

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R