BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA TEST STRIPS

    MDR report key: 3212203 · Received July 9, 2013

    Report

    Report Number
    3008382007-2013-19102
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 17, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K043197
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1. THE LAY USER/PATIENTS TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS:THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE FOUND TO HAVE SHELF LIFE EXCEEDED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT A PACKAGING ISSUE WITH HER ONETOUCH ULTRA TEST STRIPS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT CLAIMED ON AN UNKNOWN DATE/TIME IN MAY, SHE PURCHASED ONETOUCH ULTRA TEST STRIPS THAT WERE EXPIRED. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH AN UNKNOWN TYPE AND DOSE OF ORAL MEDICATION AND DENIED TAKING ANY ACTION REGARDING HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. APPROXIMATELY 24 HOURS LATER, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF ¿SWEATING AND HER PALMS WERE CLAMMY.¿ DESPITE HER SYMPTOMS, SHE DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313629 OT ULTRA TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3214762

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening