BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1081640 · Received July 22, 2008

    Report

    Report Number
    2939301-2008-01462
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 10, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/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. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON JULY 10, 2008, A PATIENT/LAYPERSON SPOKE WITH A CUSTOMER CARE ADVOCATE, CCA, ALLEGING HER ONETOUCH ULTRAMINI METER PROMPTED ONLY APPLY SAMPLE AFTER PLACING BLOOD ON THE TEST STRIP. DURING TROUBLESHOOTING FOR THE CCA, THE STRIP DREW THE SAMPLE INTO THE TEST AREA. WITH A NEW VIAL, IT DID NOT. THE CCA REPLACED ALL PRODUCTS. THE PATIENT INFORMED THE CCA THAT THE ER OBTAINED 500 MG/DL ON ITS METER ON THE PREVIOUS MONTH. THIS SENIOR MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE PATIENT ON EIGHT DAYS AFTER THE ORIGINAL DATE, AND OBTAINED MORE INFORMATION. THE ALLEGED APPLICATION ISSUE BEGAN BEFORE THE HOSPITALIZATION ACCORDING TO THE PATIENT. AND BASED ON THE PATIENT'S HISTORY, SHE CONTACTED CUSTOMER SERVICE ON SIX DAYS PRIOR TO EVENT DATE, WITH THE SAME ISSUE. ON THE SAME DAY, A CCA REPORTEDLY DISCOVERED THE PATIENT'S TEST STRIPS HAD EXPIRED 8/2005 AND SENT NEW STRIPS. IT IS NOT CLEAR WHETHER THE PATIENT WAS STILL TESTING WITH EXPIRED STRIPS ON EVENT DAY. USING A BACK UP METER, THE PATIENT REPORTEDLY CONTINUED TESTING AND TAKING HER NOVOLOG 100 ON A SLIDING SCALE. THE PATIENT DOES NOT RECALL RESULTS. ON THE SAME DAY, AN AMBULANCE REPORTEDLY TOOK THE PATIENT TO THE ER WHEN THE PATIENT'S LEGS AND FEET SWELLED AND SHE COULD NOT WALK. THE PATIENT WAS REPORTEDLY TREATED WITH INSULIN IN ER WHERE HER BLOOD GLUCOSE WAS 500, AND WAS HOSPITALIZED UNTIL THE FOLLOWING MONTH, DUE TO CONGESTIVE HEART AND KIDNEY FAILURE (THE PATIENT'S KIDNEYS WERE SHUTTING DOWN), AND UTI INFECTION. THE PATIENT'S POTASSIUM LEVEL WAS 7.1 AND HEMOGLOBIN 5 AND 6 FOR WHICH SHE RECEIVED A TRANSFUSION AND IS NOW GIVEN EPHIGREN INJECTION WEEKLY. THE HEMOGLOBIN NOW IS 12% (12% HGB IS EQUIVALENT TO A 36% HEMATOCRIT). THE PATIENT SAID THAT A FEW DAYS PRIOR TO THE DATE OF EVENT, SHE HAD BEEN DISCHARGED AFTER SPENDING TWO WEEKS IN ANOTHER HOSPITAL FOR THE SAME HEALTH CONDITIONS. THERE IS EVIDENCE THE PATIENT MAY HAVE TESTED WITH EXPIRED TEST STRIPS WHILE HAVING AN ABNORMALLY LOW HEMOGLOBIN OF 5 OR 6, BOTH OF WHICH COULD AFFECT THE FUNCTION AND RESULTS WHEN TESTING. ALSO, THE PATIENT WAS HOSPITALIZED FOR OTHER SERIOUS HEALTH ISSUES. NEVERTHELESS, BECAUSE THE PATIENT'S BLOOD GLUCOSE WAS REPORTEDLY ELEVATED AFTER THE REPORTED ISSUE, AND SHE REPORTEDLY HAD TO RECEIVE INSULIN FROM HEALTH CARE PROFESSIONALS IN THE ER, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2725290

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R