BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2993774 · Received March 7, 2013

    Report

    Report Number
    3008382007-2013-04437
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 18, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K021819
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH AN INCORRECT TIME FLAG ON HER ONETOUCH ULTRASMART METER. ON (B)(6) 2013, THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER, THE PATIENT DID NOT WANT TO ANSWER FOLLOW UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2013. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATIONS (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER USUAL MANAGEMENT ROUTINE. "IMMEDIATELY" AFTER, THE PATIENT CLAIMS SHE FELT SYMPTOMS OF SHAKY AND APPREHENSIVE. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA WALKED THE PATIENT THROUGH THE SETTINGS OPTIONS TO RESOLVE THE ALLEGED ISSUE. BASED ON THE PROVIDED INFORMATION AT THIS TIME, IT IS UNCLEAR HOW THE INCORRECT TIME FLAG ISSUE CAN LEAD TO THE PATIENT'S SYMPTOMS SINCE THE TIME SETTING DOES NOT AFFECT THE ABILITY TO TEST. THUS, THE LINKAGE BETWEEN THE REPORTED PRODUCT ISSUE AND THE ALLEGED INJURIES BY THE PATIENT REMAINS UNCLEAR. DESPITE AN ATTEMPT TO REACH THE PATIENT, THE PATIENT REFUSED TO PROVIDE FURTHER INFORMATION. IN CONCLUSION, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED TIME FLAG ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96867 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3361732

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening