BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 3893230 · Received June 25, 2014

    Report

    Report Number
    2939301-2014-15418
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 10, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K021819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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)(4) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE ONETOUCH ULTRASMART METER IS GIVING CALCODE ISSUE. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CALCODE ISSUE BEGAN ON (B)(4) 2014 AT 9 AM. AT THE TIME OF CONCERN, THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATION (METFORMIN). THE PATIENT CLAIMED THAT HE HAD SYMPTOMS DESCRIBED AS ¿SHAKY AND VOMITING¿ DUE TO THE CALCODE ISSUE. THERE WAS NO REPORT OF ANY REQUIRED HCP TREATMENT. THE CALCODE ISSUE WAS RESOLVED WITH TRAINING ON (B)(4) 2014. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY DUE TO THE ALLEGED CALCODE ISSUE. THE LFS PRODUCT WAS REPLACED AND REQUESTED BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370831 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3355690

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening