BEUDAMED
    FDA Adverse Event Death Summary report: N

    OT II METER

    MDR report key: 766261 · Received September 29, 2006

    Report

    Report Number
    2939301-2006-01359
    Event Type
    Death
    Date Received
    September 29, 2006
    Date of Event
    September 15, 2006
    Report Date
    September 25, 2006
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM.

    Description of Event or Problem · 1

    ON SEPTEMBER 25, 2006, THE LAY USER/REPORTER; THE PT'S DAUGHTER, CONTACTED LIFESCAN (LFS) ALLEGING THE ONE TOUCH II METER WAS GIVING THE "CLEAN TEST AREA" ERROR MESSAGE. THE MEDICAL AFFAIRS SPECIALIST (MAS) WAS UNABLE TO CONTACT THE PT BY TELEPHONE TO OBTAIN AND VERIFY INFO. ON SEPTEMBER 28,2006, THE MAS MAILED A LETTER REQUESTING THE PT CONTACT MED AFFAIRS. THE MAS ALSO REVIEWED THE RECORDED TELEPHONE CALL. ON SEPTEMBER 15, 2006, THE PT OBTAINED THE ERROR MESSAGE 'CLEAN TEST AREA' ON THE REPORTED METER; SHE DID NOT OBTAIN A BLOOD GLUCOSE READING. THE REPORTER WAS UNABLE TO STATE WHETHER OR NOT THE PT WAS EXPERIENCING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS. AT 3:00 PM, A NEIGHBOR CONTACTED EMERGENCY SERVICES. WHEN THE PRAMEDICS ARRIVED, THE PT'S BLOOD GLUCOSE LEVEL WAS TESTED TO BE 'LOW'. THE PT WAS TRANSPORTED TO THE EMERGENCY ROOM, WHERE SHE RECEIVED INTRAVENOUS FLUIDS. IT WOULD HAVE BEEN HELPFUL TO DETERMINE IF THE PT WAS EXPERIENCING ANY SYMPTOMS ON THE DAY OF THE EVENT, WHY EMERGENCY SERVICES WERE CONTACTED, THE PT'S BLOOD GLUCOSE LEVEL AS TESTED BY THE PARAMEDICS, HER SPECIFIC TREATMENT IN THE EMERGENCY ROOM, HOW LONG THE PT HAD BEEN UNABLE TO TEST HER BLOOD GLUCOSE LEVEL DUE TO THE ERROR MESSAGE, WHAT MEALS AND MEDICATIONS THE PT HAD TAKEN PRIPR TO THE EVENT. IF THE PT ADJUSTED HER MEDICATIONS BASED ON METER READINGS, THE PREVIOUS BLOOD GLUCOSE READINGS, HER MEDICATION REGIMEN, AND IF SHE HAD A BACKUP METER. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PT WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVEL DUE TO THE ERROR MESSAGE ON THE REPORTED METER. THE HEALTHCARE PROFESSIONAL OBTAINED A 'LOW BLOOD GLUCOSE READING FOR THE PT, AND SHE RECEIVED EMERGENCY MED ATTENTION AND INTRAVENOUS TREATMENT. NO INFO WAS PROVIDED AS TO THE PT'S SYMPTOMS. THEREFORE, THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT II METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 198022A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L| R