BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1081829 · Received July 23, 2008

    Report

    Report Number
    2939301-2008-01482
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 10, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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 22, 2008, THIS SENIOR MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE PATIENT/LAYPERSON REGARDING A REPORTER'S CALL TO CUSTOMER SERVICE ON JULY 10, 2008. THE PATIENT INFORMED ME THE REPORTER IS HIS DAUGHTER, A NURSE. THE PATIENT DOES HIS OWN TESTING AND CODING. THE REPORTER HAD COMPLAINED ABOUT SEVERAL ISSUES INCLUDING AN ALLEGED INACCURATE LOW RESULT OF "60-80" OBTAINED IN 2008 WITH HIS ONETOUCH ULTRA2 METER. AFTER THE TEST, THE PATIENT REPORTEDLY WAS THIRSTY; HOWEVER, HE DID NOT REQUIRE OR RECEIVE MEDICAL INTERVENTION. BECAUSE THE PATIENT DOES NOT RECALL THIS PARTICULAR INCIDENT, THE COMPLAINT IS CLASSIFIED BASED UPON INFORMATION THE REPORTER GAVE TO A CUSTOMER SERVICE ADVOCATE, CCA, WHO REPLACED THE TEST-STRIPS AND METER. ACCORDING TO THE METER'S MEMORY, THE PATIENT'S BLOOD GLUCOSE AFTER EATING ON EVENT DATE WAS "82". THE PATIENT WHOSE DAILY DIABETES REGIMEN IS ORAL MEDICATION, DID NOT RECEIVE MEDICAL INTERVENTION FOLLOWING THE REPORTED ISSUE. DURING TROUBLESHOOTING, THE CCA DISCOVERED THAT THE PATIENT'S ULTRA TEST STRIPS WERE ILLEGALLY RELABELED AND REPACKAGED BY AN UNKNOWN SOURCE. THESE TEST STRIPS WERE GENUINE LIFESCAN TESTSTRIPS. THIS SPECIALIST DISCUSSED THE ISSUE WITH THE PATIENT. ALTHOUGH THE PATIENT WAS ALLEGEDLY USING COUNTERFEIT TEST STRIPS AND REQUIRED NO MEDICAL INTERVENTION, THE SYMPTOM HE EXPERIENCED IS ASSOCIATED WITH SEVERE HYPERGLYCEMIA. FOR THAT REASON, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2764848

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening