BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 3230761 · Received July 17, 2013

    Report

    Report Number
    3008382007-2013-19997
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    July 5, 2013
    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
    NY, 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) 2013, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT¿S ONETOUCH ULTRAMINI METER DISPLAYED AN ¿ERROR 5¿ MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ABOUT 2 ½ WEEKS PRIOR TO CONTACTING LFS. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATIONS (TYPE/ AMOUNT NOT SPECIFIED). THE PATIENT CONTINUED TO ADMINISTER HER USUAL DOSE OF MEDICATIONS. LATER THAT SAME DAY, THE REPORTER CLAIMED THE PATIENT FELT A SYMPTOM OF FATIGUE. TREATMENT WAS NOT SPECIFIED AT THAT TIME. ON (B)(6) 2013, THE PATIENT REPORTEDLY VISITED THE URGENT CARE/ CLINIC AND WAS ADMINISTERED INSULIN (TYPE/ AMOUNT NOT SPECIFIED) AS TREATMENT. THE ALLEGED ISSUE WAS NOT RESOLVED WITH RETESTING AT THE TIME OF TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY 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
    330820 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3471195

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R