BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2215279 · Received August 17, 2011

    Report

    Report Number
    2939301-2011-07571
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 21, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 K043197. ULTRA TEST STRIPS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRAMINI METER WAS NOT WORKING DUE TO INCORRECT TEST STRIPS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CONVERSATION BETWEEN THE PATIENT AND THE CUSTOMER CARE ADVOCATE (CCA) BECAUSE THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/ PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE MSS REVIEWED THE CALL TO OBTAIN AND VERIFY INFORMATION. THE PATIENT REPORTED THAT ONE WEEK PRIOR TO CONTACTING LFS, HE HAD DIFFICULTY INSERTING A TEST STRIP INTO THE SUBJECT METER AND WAS THEREFORE UNABLE TO CHECK HIS BLOOD GLUCOSE. THE PATENT STATED HE MANAGES HIS DIABETES WITH 70/30 HUMULIN INSULIN AND LANTUS INSULIN (SELF ADJUSTER). THE PATIENT STATED HE WAS CONSUMING LESS FOOD/DRINK FOR APPROXIMATELY ONE WEEK PRIOR TO THE ALLEGED ISSUE AND CONTINUED TO EAT AND DRINK LESS AFTER THE ALLEGED ISSUE. IT WOULD HAVE BEEN HELPFUL TO KNOW IF THE PATIENT MADE ANY CHANGES TO HIS DIABETES MEDICATIONS AFTER HE WAS UNABLE TO CHECK HIS BLOOD GLUCOSE. THE PATIENT CLAIMED HE WAS HOSPITALIZED ON (B)(6) 2011 (UNKNOWN TIME) FOR 'HIGH BLOOD SUGARS'. THE PATIENT DENIED DEVELOPING SYMPTOMS; IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT LED TO THE HOSPITALIZATION. THE PATIENT CLAIMED HE WAS TREATED AT THE HOSPITAL BY AN HCP WITH INSULIN (70/30 MIX) AND METFORMIN PILLS AND WAS RELEASED ON (B)(6) 2011. AFTER BEING RELEASED FROM HOSPITAL, THE PATIENT STATED HE USED HIS SISTER'S BLOOD GLUCOSE METER (UNKNOWN TYPE) AND RECEIVED READING(S) IN THE '250-300 MG/DL' RANGE. AT THE TIME OF TROUBLESHOOTING, THE CCA IDENTIFIED THE TEST STRIPS AS BEING 'FREESTYLE' TEST STRIPS. THE PATIENT CLAIMED THEY WERE IN THE VIAL OF ONETOUCH TEST STRIPS WHEN HE RECEIVED THEM AND WAS UNAWARE THAT THEY WERE INCORRECT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY WAS HOSPITALIZED AND TREATED FOR SEVERE HYPERGLYCEMIA AFTER THE ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2991839

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization