BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1203678 · Received October 9, 2008

    Report

    Report Number
    2939301-2008-02589
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    September 28, 2008
    Report Date
    September 29, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    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

    IN 2008, A PATIENT/LAYPERSON COMPLAINED THAT A 31MG/DL RESULT SHE OBTAINED WITH HER ONE TOUCH ULTRALINK METER TWO DAYS PRIOR, WAS INACCURATELY LOW. IT WAS UNCLEAR WHY THE PATIENT THOUGHT HER METER WAS LOW, SINCE NO OTHER RESULTS WERE PROVIDED. REPORTEDLY, THE PATIENT WAS IN A DIABETIC COMA BEFORE SHE OR ANOTHER ATTEMPTED TO TEST ON THE SUBJECT METER, AFTER WHICH SHE WAS TREATED IN THE HOSPITAL WITH IV DEXTROSE. THE CUSTOMER CARE ADVOCATE, CCA, REPLACED THE PATIENT'S METER AND TEST STRIPS. THIS SENIOR MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE PATIENT THE FOLLOWING MONTH. THE PATIENT REPORTED THE FOLLOWING: THE PATIENT CLARIFIED THAT SHE HAD BEEN EXPERIENCING LOW BLOOD GLUCOSES RECENTLY, SOME IN THE 30'S, SINCE HER DOCTOR INCREASED THE BASAL RATE IN HER PUMP FROM 1.5 AND 2.5 AN HOUR TO 3.5 AN HOUR, AS WELL AS, LOWERED HER CARB RATIO FROM 1 TO 7 DOWN TO 1 TO 5. THE CHANGES WERE THE RESULT OF AN INFECTION THAT INCREASED HER BLOOD GLUCOSES FOLLOWING DENTAL SURGERY. ON TWO DAYS PRIOR TO ORIGINAL DATE, THE PATIENT'S BLOOD GLUCOSE WAS 96 WHEN SHE WENT TO BED. BECAUSE HER PUMP'S BASAL RATE WAS HIGHER, SHE BELIEVES IT RESULTED IN THE HYPOGLYCEMIA THE NEXT MORNING. ON ORIGINAL DATE AT 5:00 A.M., THE PATIENT'S HUSBAND CALLED 911 WHEN HE COULD NOT AWAKEN HER TO PREPARE FOR A TRIP. HE DID NOT TEST HER BLOOD GLUCOSE. EMT'S METER RESULT WAS 31. UNABLE TO START AN IV FOR DEXTROSE, EMT IMMEDIATELY DROVE HER TO THE ER WHERE HER "TEMPERATURE WAS 94" AND SHE WAS TREATED WITH DEXTROSE. SEVERAL HOURS LATER SHE WOKE UP. WHEN THE PATIENT'S BLOOD GLUCOSE DROPPED THE NEXT DAY IN THE HOSPITAL, FOLLOWING A 414 OBTAINED ON HER METER AND 350 ON THE HOSPITAL'S (WITHIN AN EXPECTED <=30% VARIANCE), THE STAFF LOWERED THE BASAL RATE THE FOLLOWING DAY, TO 1.0 PER HOUR AND RAISED THE CARB RATION TO 1-7 AND THEN 1-10. AFTER A BLOOD GLUCOSE TEST, THE PATIENT USES HER BOLUS WIZARD TO CALCULATE A RESULT AND HER CARBS TO GENERATE HOW MUCH TO DELIVER. THE PATIENT REPORTEDLY ALWAYS EXPERIENCED AND EXPERIENCES SYMPTOMS OF THIRST AND FREQUENT URINATION, WHEN HER BLOOD GLUCOSES WERE AND ARE ELEVATED. BECAUSE THE PATIENT WAS SYMPTOMATIC ON ORIGINAL DATE, AND WAS NOT TESTED ON HER METER AND TESTED ONLY BY EMT, THERE IS NO INDICATION THE PRODUCT CONTRIBUTED TO THE SERIOUS INJURY. THE PATIENT ALSO ATTRIBUTED THE INJURY TO THE BASAL RATE INCREASE AND CARB DECREASE. THE PATIENT DID QUESTION COMPARISONS BETWEEN HER METER AND THE HOSPITAL'S NEW METER WHILE HOSPITALIZED, WHEN HER METER'S RESULTS WERE HIGHER. THE HOSPITAL USED BLOOD THE SAME FINGER STICK EACH TIME THEY RAN COMPARISONS. TWO OF FOUR COMPARISON'S WERE WELL WITHIN THE EXPECTED VARIANCE OF <==30%. BECAUSE ONE FROM COMPARISON OF 315 AND 238 AND MUCH LATER 151 AND 115 WERE BOTH A 32 AND 31% DIFFERENCE, THE COMPLAINT IS CLASSIFIED AS AN ACCURACY AND PRECISION. NO INJURY WAS RECEIVED AS A RESULT OF THE VARIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2858131

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR