BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3901192 · Received June 30, 2014

    Report

    Report Number
    2939301-2014-15763
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 17, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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) USA, ALLEGING THAT THE ONETOUCH ULTRAMINI METER IS GIVING AN ERROR 5 ISSUE. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTEDLY ENCOUNTERED THE ERROR 5 ISSUE ABOUT A MONTH AGO. THE PATIENT INDICATED THAT HE MANAGED HIS DIABETES WITH MORE FOOD/DRINK AT THE TIME OF CONCERN. LAST WEEK, THE PATIENT WAS TESTED ON THE EMS METER AT ¿35 MG/DL¿ AND REQUIRED HCP TREATMENT WITH FOOD/DRINK. THERE WAS NO REPORT OF ANY SYMPTOMS. DURING TROUBLESHOOTING, THE ERROR 5 ISSUE WAS NOT RESOLVING WITH TRAINING. THE TESTING PROCESS WAS PER THE OWNER¿S MANUAL. THE TEST SAMPLE WAS DRAWN INTO THE TEST STRIP COMPLETELY. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REQUIRED HCP TREATMENT FOR A BLOOD GLUCOSE READING OF ¿35 MG/DL¿ AFTER THE ERROR 5 ISSUE BEGAN. THE LFS PRODUCT WAS REPLACED AND REQUESTED BACK FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379622 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3494241

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R