BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCH ULTRA METER

    MDR report key: 1060321 · Received June 13, 2008

    Report

    Report Number
    2939301-2008-01073
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 18, 2008
    Report Date
    May 18, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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

    THIS SENIOR MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE REPORTER/LAYPERSON (HUSBAND) OF THE PATIENT/LAYPERSON ON JUNE 6, 2008. THE REPORTER HAD ALLEGED TO A CUSTOMER CARE ADVOCATE, CCA, ON THE PREVIOUS MONTH THAT A HYPOGLYCEMIC EVENT THE SAME DAY MAY HAVE BEEN DUE TO INACCURATE HIGH RESULTS WITH CONTROL SOLUTION ON THE PATIENT'S ONETOUCH ULTRA METER. THE CCA REPLACED ALL PRODUCTS. RESULTS ARE IN THE CORRECT UNIT OF MEASURE, MG/DL. THE REPORTER PERFORMS ALL TESTS AND INJECTS ALL INSULIN FOR THE PATIENT. AT 6:30 PM ON THE SAME DAY, THE PATIENT'S BLOOD GLUCOSE WAS REPORTEDLY 81 MG/DL. REPORTEDLY, SHE "FELT OK." THE REPORTER INJECTED HER USUAL EVENING DOSE OF 20 UNITS LANTUS BEFORE THEY DROVE TO A RESTAURANT FOR DINNER. TWENTY MINUTES LATER BEFORE REACHING THE RESTAURANT, THE PATIENT BEGAN TO SHAKE. THE REPORTER GAVE HER A COKE THAT "DIDN'T CALM HER DOWN" AND DROVE HOME. SEVEN TO EIGHT MINUTES LATER UPON ARRIVING AT HOME, THE REPORTER TRIED TO GIVE HER ORANGE JUICE. "SHE WAS IN SHOCK BUT AWAKE." FIVE TO TEN MINUTES LATER, EMT ARRIVED AND TREATED WITH IV GLUCOSE. THE PATIENT RECOVERED "FAST". THE REPORTER HAD NOT TESTED THE PATIENT HIMSELF AND DOES NOT RECALL THE EMT'S METER RESULT. THE PATIENT REFUSED TRANSPORTATION TO THE HOSPITAL. THE EMT SUGGESTED THE REPORTER TEST PRODUCT WITH CONTROL SOLUTION THAT FELL OUTSIDE OF THE RANGE. RANGE 90-120 AND RESULTS 124, 128, 129, AND 126. ALTHOUGH THE PATIENT ALSO IS GIVEN NOVOLOG DEPENDING UPON HER BLOOD GLUCOSE RESULTS, THE REPORTER DOES NOT RECALL IF HE HAD GIVEN NOVOLOG EARLIER IN THE DAY. IF HE HAD, THE NOVOLOG WOULD STILL HAVE BEEN WORKING. ON FOUR DAYS PRIOR TO ORIGINAL DATE, THE PATIENT'S PHYSICIAN SAW HER AS A FOLLOW-UP TO THE EMT VISIT. THE PHYSICIAN RECOMMENDED THAT THE PATIENT BEGIN TAKING THE LANTUS AFTER EATING THE EVENING MEAL RATHER THAN BEFORE. ORIGINALLY, THE PATIENT WAS TAKING IT BEFORE BED. BECAUSE SHE WOKE UP WITH LOW GLUCOSES, THE PHYSICIAN HAD CHANGED HER LANTUS TO PRE EVENING MEALS. THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT BECAUSE THE PATIENT WAS REPORTEDLY TREATED BY EMT FOR SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R