BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA TEST STRIPS #100

    MDR report key: 1080836 · Received July 23, 2008

    Report

    Report Number
    MW5007740
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 10, 2008
    Report Date
    July 15, 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

    UPON RECEIPT OF NEW TEST VIALS, PT TESTED USING CONTROL SOLUTION. WHEN THE READINGS CAME BACK OUT- OF- RANGE FOR 2 DIFFERENT VIALS THE PT PHONED CITY PHARMACY. PT WAS ADVISED TO CALL THE MFR, LIFESCAN, INC, WHERE HE WAS INFORMED THAT ILLEGALLY RELABELED/REPACKAGED ONE TOUCH ULTRA TEST STRIPS HAD BEEN FOUND IN THE UNITED STATES. PT RETUNED #200 TEST STRIPS TO THE PHARMACY AND WAS GIVEN NEW VIALS THAT WERE NOT INCLUDED ON THE LIST OF COUNTERFEIT LOT NUMBERS. PHARMACY QUARANTINED THE RETURNED TEST STRIPS. DOSE OR AMOUNT: CHECK BLOOD GLUCOSE FREQUENCY: 4 TIMES 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 NONE NBW LIFESCAN, INC 2779173

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention