BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2792573 · Received October 16, 2012

    Report

    Report Number
    2939301-2012-12064
    Event Type
    Injury
    Date Received
    October 16, 2012
    Report Date
    September 18, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K021819
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 THAT HER ONETOUCH ULTRASMART METER PROMPTING AN UNSPECIFIED ERROR MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE INFORMATION OBTAINED BY THE CUSTOMER CARE ADVOCATE (CCA). THE PATIENT STATED THAT THE ALLEGED ISSUE BEGAN AT 4 P.M. ON (B)(6) 2012. THE PATIENT REPORTED MANAGING HER DIABETES WITH INSULIN (SELF ADJUSTING) AND DENIED MAKING ANY CHANGES TO HER NORMAL DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS OF "SWEAT AND SHAKY" 15 MINUTES AFTER THE ALLEGED ISSUE BEGAN. HOWEVER, THE PATIENT DENIED RECEIVING MEDICAL INTERVENTION AS A RESULT OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING THE PATIENT WAS UNABLE TO RECALL THE SPECIFIC ERROR MESSAGE. THE ALLEGED ISSUE WAS RESOLVED DURING TROUBLESHOOTING. HOWEVER, REPLACEMENT PRODUCT WAS STILL SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AS A RESULT OF THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3328743

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR