BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2901961 · Received January 8, 2013

    Report

    Report Number
    3008382007-2013-00271
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 22, 2012
    Report Date
    December 22, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K072543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH SELECT METER WAS DISPLAYING AN APPLY SAMPLE MESSAGE AFTER THE SAMPLE HAD BEEN APPLIED. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(4) 2013 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT INFORMED THE MSS THAT THE ALLEGED ISSUE BEGAN ON THE SAME DAY SHE CONTACTED LFS FOR ASSISTANCE AT APPROXIMATELY 7AM. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH 1 METFORMIN PILL AND 1 GLIPIZIDE PILL (DOSE UNKNOWN) IN THE MORNING AND LUNCHTIME AND SHE CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE. SHE CLAIMED THAT IMMEDIATELY AFTER ATTEMPTING TO TEST WITH THE SUBJECT METER, SHE DEVELOPED SYMPTOMS OF FEELING 'BLURRY VISION' WHICH SHE ASSOCIATED WITH HIGH BLOOD GLUCOSE AND ADVISED THE MSS THAT HER BLOOD GLUCOSE WAS RUNNING HIGH LATELY, NO RESULTS OF CONCERN REPORTED. SHE STATED SHE DRANK WATER, LAY DOWN AND FELT BETTER WITHIN 2 HOURS. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS NOT BEING USED FOR THE FIRST TIME. THE SUBJECT TEST STRIPS WERE IN GOOD CONDITION AND THE TESTING TECHNIQUE WAS INCORRECT. THE ISSUE WAS RESOLVED WITH TRAINING AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8782 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3333735

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening