BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2083344 · Received May 10, 2011

    Report

    Report Number
    2939301-2011-03845
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (06/09/2011)-DEVICE EVALUATION: THE LAY USER/PATIENT'S METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE PCB CONTAMINATION. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRASMART 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 (B)(6) 2011 AT 3:00 AM WHEN THE SUBJECT METER WAS DROPPED IN THE WATER. THE PATIENT CLAIMED HE MANAGES HIS DIABETES WITH COMBINATIONS OF INSULINS. AT THE TIME THE ALLEGED ISSUE BEGAN, THE PATIENT INDICATED HE ADMINISTERED 30 UNITS OF LANTUS AND 4 UNITS OF NOVOLIN. THE PATIENT INDICATED HE BECAME LIGHTHEADED ½ AN HOUR AFTER THE ALLEGED ISSUE BEGAN. SINCE THE PATIENT WAS NOT ABLE TO TEST ON THE SUBJECT METER, THE PATIENT STATED EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED FOR ASSISTANCE. WHEN THE EMS ARRIVED, THE PATIENT STATED HE WAS TESTED BY THE EMS METER WITH RESULTS OF "54, 54, AND 68 MG/DL" AT 5:00 AM THAT MORNING. ACCORDING TO THE CCA DOCUMENTATION, AFTER BEING TESTED BY THE EMS METER, THE PATIENT WAS ADVISED TO EAT. THE PATIENT STATED A NON-HEALTH CARE PROVIDER TREATED HIM WITH FOOD AND/OR DRINK. 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 REQUIRING TREATMENT FROM A NON-HEALTH CARE PROFESSIONAL (HCP) AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3112404

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention