BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 612308 · Received June 6, 2005

    Report

    Report Number
    2939301-2005-02542
    Event Type
    Death
    Date Received
    June 6, 2005
    Date of Event
    February 24, 2005
    Report Date
    May 27, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT'S FAMILY MEMBER CALLED LIFESCAN BECAUSE THE FAMILY MEMBER RECEIVED LIFESCAN'S LETTER PROVIDING ULTRA METER USERS WITH INFORMATION REGARDING THE UNIT OF MEASURE. THE FAMILY MEMBER, WHO ALLEGED THAT PT'S METER WAS SET IN MMOL/L, PROVIDED THE FOLLOWING INFORMATION. PT WHO HAD A HISTORY OF CONGESTIVE HEART FAILURE, HAD BEEN IN ASSISTED LIVING SINCE 2002, FOLLOWING A STROKE. ON INSULIN BEFORE THE STROKE, THE PT WAS ON AMARYL, LIPITOR, AND CARDIZEM. THE PT DID NOT KEEP A LOG OF PT'S GLUCOSES NOR WAS THE ASSISTED LIVING STAFF INVOLVED IN MONITORING PT'S GLUCOSE. HOWEVER, THE PT TOLD FAMILY MEMBER THAT THEIR SUGAR WAS "102 OR 111." IF PT'S RESULTS WERE "OVER 200, PT WAS SUPPOSED TO TELL THE ASSISTED LIVING PERSONNEL. REPORTEDLY, PT'S GLUCOSE WAS NEVER OVER 200. FAMILY MEMBER BROUGHT THE PT TO AN INTERNIST EVERY 6 WEEKS. HE OBTAINED BLOOD GLUCOSES IN THE 250, 260, AND 270 RANGE AT THE 3:00 OR 3:30 P.M. OFFICE VISITS. HE ATTRIBUTED THE ELEVATED GLUCOSE RESULTS TO THE PT'S HAVING HAD LUNCH TREE HOURS EARLIER, "SO HE WAS NOT CONCERNED." THE FAMILY MEMBER DOES NOT KNOW WHETHER THE INTERNIST OBTAINED HBA1C'S. IN EARLY 2005, THE PT WAS HOSPITALIZED FOR RENAL FAILURE. THE 3RD DAY, WHILE IN RE-ADMITTED, FROM REHAB, FOR RENAL FAILURE. BLOOD GLUCOSE WHILE IN HOSPITAL WAS IN THE 280 MG/DL RANGE (POSSIBLY ON THE HOSPITAL'S METER). DURING BOTH ADMISSIONS, THE PT WAS TREATED WITH INSULIN ON A SLIDING SCALE IF PT'S GLUCOSE WAS OVER 200. ADITTING BLOOD GLUCOSE IS NOT KNOWN FOR EITHER ADMISSION. THE PT WAS TRANSFERRED TO A HOSPICE, WHERE PT PASSED AWAY A WEEK LATER. THE CAUSE OF DEATH "CONGESTIVE HEART FAILURE." THE ONLY OTHER HOSPITALIZATIONS DURING 2003 AND 2004 HAD BEEN ONE FOR EYE SURGERY IN 2003 AND ONE FOR CONGESTIVE HEART FAILURE IN 11/2004. THERE WERE NO HOSPITALIZATIONS RELATED TO DIABETIC CONTROLS. LIFESCAN'S EXAMINATION OF THE METER SUGGESTS THAT THE INCORRECT UNIT OF MEASURE WAS DUE TO USE ERROR THERE IS NO EVIDENCE THAT THE PT SUFFERED AN ADVERSE EVENT OR THAT PT DEATH WAS DUE TO THE METER BEING IN THE INCORRECT UNIT OF MEASURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death