BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA TEST STRIPS #100

    MDR report key: 1081414 · Received July 24, 2008

    Report

    Report Number
    MW5007787
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    AFTER HAVING USED 3 OUT OF 4 VIALS PROVIDED IN A #100 COUNT BOX OF TEST STRIPS, PT TESTED THE FOURTH VIAL USING CONTROL SOLUTION. WHEN THE READINGS CAME BACK OUT-OF-RANGE FOR 3 DIFFERENT TEST STRIPS, THE PT PHONED CITY PHARMACY. PT WAS ADVISED TO RETURN THE VIAL TO THE PHARMACY. PT RETURNED #25 TEST STRIPS TO THE PHARMACY AND WAS GIVEN A REPLACEMENT VIAL OF TEST STRIPS THAT WAS NOT INCLUDED ON THE LIST OF COUNTERFEIT LOT NUMBERS. PHARMACY QUARANTINED THE RETURNED TEST STRIPS. DOSE OR AMOUNT: CHECK BLOOD GLUCOSE. FREQUENCY: ONCE A DAY. ROUTE: 003. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: DIABETES MELLITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA TEST STRIPS #100 NBW LIFESCAN INC. 2769226

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention