BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3882572 · Received June 19, 2014

    Report

    Report Number
    2939301-2014-14799
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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) 2014, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA2 METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2014 ABOUT 8AM. THE PATIENT MANAGES HIS DIABETES WITH INSULIN. IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS USUAL DOSE OF MEDICATIONS AT THE TIME OF THE REPORTED ISSUE. THE PATIENT DENIED DEVELOPING SYMPTOMS; HOWEVER, AT 920AM THAT SAME MORNING, THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM (ER) AND OBTAINED A BLOOD GLUCOSE RESULT OF ¿514 MG/DL¿ WITH THE ER/ HOSPITAL METER. THE PATIENT WAS ADMINISTERED NOVOLOG INSULIN (30 UNITS) AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE CORRECT TEST STRIPS WERE BEING USED AND THERE WAS NO INDICATION OF MISUSE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TRAINING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT SUGGESTIVE OF A SERIOUS INJURY WITH AN ER/ HOSPITAL METER AND RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361968 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3611643

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening| R