BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2510009 · Received March 29, 2012

    Report

    Report Number
    2939301-2012-03017
    Event Type
    Injury
    Date Received
    March 29, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 13, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. THE 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRAMINI METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2012, AT 8AM. THE PATIENT MANAGES HIS DIABETES WITH LANTUS INSULIN (30 UNITS) AND HUMULIN R INSULIN (8 UNITS). THE PATIENT CONTINUED TO TAKE HIS USUAL DOSE OF MEDICATIONS. THE PATIENT DENIED DEVELOPING SYMPTOMS. ABOUT 130PM THAT SAME DAY, THE PATIENT WENT TO THE EMERGENCY ROOM (ER)/ HOSPITAL. THE PATIENT REPORTED A BLOOD GLUCOSE RESULT OF "518 MG/DL" ON THE ER METER AND WAS ADMITTED INTO THE HOSPITAL. A HEALTH CARE PROFESSIONAL (HCP) ADMINISTERED THE PATIENT INSULIN (TYPE/ AMOUNT NOT SPECIFIED) AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS NOT ABLE TO WALK THE PATIENT THROUGH RESOLVING THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HCP AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| L| R