BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2598098 · Received June 5, 2012

    Report

    Report Number
    2939301-2012-05927
    Event Type
    Injury
    Date Received
    June 5, 2012
    Date of Event
    May 16, 2012
    Report Date
    May 27, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY LOW COMPARED TO HER FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON THE MORNING OF (B)(6) 2012, THE PATIENT REPORTED OBTAINING 200, 239, 289 AND 375MG/DL ON HER LFS METER. THE PATIENT REPORTED MANAGING HER DIABETES WITH A COMBINATION OF MEDICATIONS INCLUDING NOVOLOG, SLIDING SCALE AND NOVOLIN, 25 UNITS IN THE MORNING AND 45 UNITS IN THE EVENING. THE PATIENT REPORTED FOR THE PAST 2 WEEKS PRIOR TO CONTACT LFS, THE PATIENT HAS INCREASED HER DOSE OF NOVOLOG INSULIN 2-8 UNITS DEPENDING ON HER READINGS, AND HAS EATEN MORE PROTEIN. THE PATIENT REPORTED 4 DAYS AFTER THE ALLEGED ISSUE BEGAN SHE DEVELOPED SYMPTOMS OF LOW BLOOD SUGAR INCLUDING ''SWEATING AND SHAKES.'' IT IS UNKNOWN IF THE PATIENT WAS TREATED IN RESPONSE TO DEVELOPING THESE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER'S UNIT OF MEASURE WAS CORRECT. THE TEST STRIPS THE PATIENT WAS USING WERE IN GOOD CONDITION. A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED TESTING ON HER LFS METER, OBTAINING INACCURATE HIGH READINGS, ADMINISTERED INSULIN BASED ON THOSE READINGS, AND DEVELOPED SYMPTOMS OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3292756

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R