BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA TEST STRIPS

    MDR report key: 2445853 · Received February 10, 2012

    Report

    Report Number
    2939301-2012-01416
    Event Type
    Injury
    Date Received
    February 10, 2012
    Date of Event
    January 14, 2012
    Report Date
    February 1, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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. THE 510(K) # IS K043197.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A TEST STRIP ISSUE WITH TWO DIFFERENT VIALS OF HER ONETOUCH ULTRA BLUE TEST STRIPS. THIS REPORT IS IN REGARDS TO (B)(4). THE COMPLAINT WAS CLASSIFIED BASED ON THE (B)(4) FOLLOW UP CALL ON (B)(6) 2012. THE (B)(4) WAS ADVISED BY THE PATIENT THAT AT AN UNSPECIFIED TIME ON (B)(6) 2012, SHE DISCOVERED "BLACK MARKS INSIDE THE CONFIRMATION WINDOW" ON THE STRIPS FROM LOT NUMBER 3208383. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH INSULIN, 60 UNITS OF LANTUS, AND DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. APPROXIMATELY FIVE MINUTES AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF FEELING "HOT, DIZZY, AND SWEATY", AND SHORTLY AFTER, SELF TREATED WITH FOOD/DRINK AND "FELT BETTER AFTERWARDS". THE PATIENT INFORMED THE (B)(4) THAT SHE EXPERIENCED THE SAME ALLEGED TEST STRIP ISSUE WITH A DIFFERENT LOT NUMBER, 3208385. THE CCA NOTED THAT THE PATIENT'S ALLEGED ISSUE REMAINS UNRESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS THAT THE ALLEGED ISSUE PREVENTED HER FROM TESTING HER BLOOD GLUCOSE SUBSEQUENTLY, CAUSING HER TO DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND RECEIVED MEDICAL TREATMENT FOR AN ACUTE COMPLICATION OF DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA TEST STRIPS GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3208383

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Life Threatening| R