BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCH ULTRA TEST STRIPS

    MDR report key: 1469358 · Received August 27, 2009

    Report

    Report Number
    MW5012633
    Event Type
    Malfunction
    Date Received
    August 27, 2009
    Date of Event
    August 27, 2009
    Report Date
    August 27, 2009
    Manufacturer
    LIFESCAN, A JOHNSON & JOHNSON COMPANY
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I REC'D A GRAY, OPENED BOX, MARKED "MAIL ORDER ONLY - NOT FOR STORE SALE" WITH TWO, OBVIOUSLY, OPENED AND MARKED-UP VIALS OF ONETOUCH ULTRA TEST STRIPS. THE LOT NUMBER IS 2852756, EXPIRATION 01/2010. I PURCHASED THESE FROM ONLINE. I CONTACTED ONLINE STORE AND REC'D THIS REPLY: I REC'D THIS REPLY. THE EXPIRATION DATE IS NOTED IN THE LISTING. THE LISTING ALSO STATES THAT YOU WILL RECEIVE A MAIL ORDER BOX -GRAY- OR RETAIL -BLUE-. I WILL ATTACH YOUR RECEIPT AS THIS INFO IS LISTED THERE AS WELL. ALL OF OUR ITEMS ARE NEW AND SEALED WHEN THEY ARE SHIPPED. IF YOU FEEL WE HAVE MADE AN ERROR OR THERE WAS DAMAGE DURING SHIPMENT, PLEASE SEND THE ITEM BACK AND WE WILL LOOK INTO THE MATTER AND REFUND THE ORDER. OUR RETURN ADDRESS IS:" THE "LISTING" DOES NOT STATE THAT A "GRAY" BOX MAY BE SENT. THE "LISTING" DOES NOT STATE THE "EXPIRATION DATE". THE ITEM WAS NOT NEW AND WAS NOT SEALED. I DID NOT "FEEL" THEY MADE AN ERROR - I KNOW THEY ARE RE-SELLING, PRE-OWNED TEST STRIPS ILLEGALLY. I CONTACTED LIFESCAN. THEY INSTRUCTED THEY ARE SENDING ME A MAILING PACKAGE TO RETURN THE VIALS TO THEM. THEY SAID THAT ONLINE AND ITS SELLERS ARE NOT AUTHORIZED TO DISTRIBUTE OR SELL THESE TEST STRIPS. IN ADDITION, I NOTICED THAT ONLINE STORE IS NOW SELLING DIABETIC TEST STRIPS PRINTED IN ENGLISH AND TWO FOREIGN LANGUAGES. I ONLY MENTION THIS BECAUSE SOMEONE FROM THE FDA TOLD ME THERE WERE SOME PROBLEMS WITH TEST STRIPS BEING SOLD. ONLINE STORE DOES NOT CARE ABOUT ANY OF THIS. THEY CLAIM THEY CANNOT POSSIBLY KEEP TRACK OF ALL THE SELLERS ON THEIR SITE NOR CAN THEY EVEN POLICE THEMSELVES. IT'S JUST A BIG, OPEN WORLD-WIDE MARKETPLACE FOR ILLEGAL MEDICAL DEVICES AND DRUGS AND OTHER SUPPLIES. DIAGNOSIS: DIABETES MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCH ULTRA TEST STRIPS DIABETIC TEST STRIPS NBW LIFESCAN, A JOHNSON & JOHNSON COMPANY 2852756

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other