BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1955439 · Received January 10, 2011

    Report

    Report Number
    2939301-2011-00322
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 27, 2010
    Report Date
    December 29, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE PCB CONTAMINATION. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER 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. 510(K) # IS K021819.

    Description of Event or Problem · 1

    ON (B)(6), 2010 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 THE MORNING OF (B)(6), 2010. THE PATIENT INFORMED THE CCA THAT HE MANAGES HIS DIABETES WITH ORAL MEDICATIONS AND DIET/EXERCISE. DESPITE THE ALLEGED ISSUE, THE PATIENT STATED HE CONTINUED TAKING HIS NORMAL DOSE OF METFORMIN (50MG) AND GLIPIZIDE (10MG) PILLS. A DAY AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED HE WAS FEELING SHAKY. ON THE SAME DAY OF THE ALLEGED SYMPTOM, THE PATIENT CLAIMED HE TESTED WITH A RESULT OF ABOUT "200 MG/DL" ON ANOTHER METER (BRAND UNKNOWN) AND INCREASED HIS ORAL DOSE OF MEDICATIONS TO 1 PILL. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT HAD USED THE SUBJECT METER BEFORE, THE CORRECT TEST STRIPS WERE USED, THERE WAS NO MISUSED OF THE METER, AND REQUIRED NO BATTERY REPLACEMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST ON THE SUBJECT METER AND REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY A DAY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3076026

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R