BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1955370 · Received January 10, 2011

    Report

    Report Number
    2939301-2011-00306
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 17, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON THE EVENING OF (B)(6), 2010. THE PATIENT INDICATED SHE MANAGES HER DIABETES WITH INSULIN (HUMALOG). DUE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE DECREASED HER DOSE OF INSULIN TO 5 UNITS LESS BASED ON CARBOHYDRATES SHE HAD EATEN. THE FOLLOWING MORNING, THE PATIENT STATED SHE WAS FEELING THIRSTY AFTER THE ALLEGED ISSUE BEGAN. IN SPITE OF THE SYMPTOM, THE PATIENT DENIED SEEKING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED THIS WAS THE FIRST TIME THE PATIENT HAD USED THE SUBJECT METER AND THAT THE SUBJECT METER NEEDED NO BATTERY REPLACEMENT. THE ALLEGED POWER ISSUE WAS NO RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY BECAME HYPERGLYCEMIC AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2961183

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Life Threatening