BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 3911401 · Received July 3, 2014

    Report

    Report Number
    2939301-2014-16353
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 29, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K021819
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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 ULTRASMART METER POWERS OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2014 AROUND 9PM. THE PATIENT MANAGES HIS DIABETES WITH INJECTIONS (TYPE NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS USUAL MANAGEMENT ROUTINE. THE PATIENT DID NOT SPECIFY DEVELOPING SYMPTOMS; HOWEVER, ABOUT 1130PM THAT SAME EVENING, THE PATIENT REPORTEDLY WENT TO THE EMERGENCY ROOM (ER) AND OBTAINED A BLOOD GLUCOSE RESULT OF ¿40 MG/DL¿ WITH THE ER/ HOSPITAL METER. THE PATIENT WAS ADMINISTERED INTRAVENOUS (IV) GLUCOSE AS TREATMENT. THERE WAS NO INDICATION OF MISUSE. THE ALLEGED ISSUE WAS NOT RESOLVED AT THE TIME OF TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT ALLEGEDLY OBTAINED A BLOOD GLUCOSE RESULT WITH AN ER/ HOSPITAL METER SUGGESTIVE OF A SERIOUS INJURY 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
    390586 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3503063

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R