BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA TEST STRIPS

    MDR report key: 2069043 · Received April 25, 2011

    Report

    Report Number
    2939301-2011-03370
    Event Type
    Injury
    Date Received
    April 25, 2011
    Report Date
    April 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. PATIENT'S DATE OF BIRTH INFORMATION PROVIDED-(B)(6). PATIENT'S GENDER INFORMATION PROVIDED- MALE. PATIENT'S WEIGHT INFORMATION PROVIDED-(B)(6). (STRIP LOT#) INFORMATION WAS NOT PROVIDED. 510(K) # IS K043197.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S REPORTER CONTACTED LIFESCAN (LFS) ALLEGING TEST STRIPS WERE MISSING FROM THE PATIENT'S ONETOUCH ULTRA TEST STRIPS VIAL. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S REPORTER REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) (YEAR NOT SPECIFIED) AT 3:00PM. THE REPORTER INFORMED THE CCA THAT THE PATIENT MANAGES HIS DIABETES WITH PILLS AND DIET/EXERCISE. AT THE TIME THE ALLEGED ISSUE BEGAN, THE REPORTER INDICATED THE PATIENT DID NOT TAKE ANY ACTION REGARDING HIS DIABETES REGIMEN. THE REPORTER CLAIMED THE PATIENT BECAME WEAK, AGITATED, AND WAS TREMBLING 7 DAYS AFTER THE ALLEGED ISSUE BEGAN. IN SPITE OF THE SYMPTOMS, THE REPORTER STATED THE PATIENT DID NOT RECEIVE ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE CLOSURE SEAL ON THE PACKAGING WAS INTACT PRIOR TO OPENING AND EDUCATED THE PATIENT ON THE CORRECT BOX CONTENTS. THE CCA DISCOVERED THERE WERE MISSING TEST STRIPS FROM THE KIT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S REPORTER CLAIMS THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening