BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2074260 · Received May 2, 2011

    Report

    Report Number
    2939301-2011-03543
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 24, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH CODING HER ONETOUCH ULTRAMINI METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 725PM. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH GLIPIZIDE PILLS (2.5 MG). THE PATIENT CONTINUED TO TAKE HER USUAL DOSE OF MEDICATION. ABOUT 10-15 MINUTES AFTER THE ALLEGED ISSUE BEGUN, THE PATIENT CLAIMED SHE FELT A SYMPTOM OF SWEATY. AT THE TIME OF TROUBLESHOOTING, THE CCA WALKED THE PATIENT THROUGH CORRECTLY CODING THE SUBJECT METER TO MATCH THE TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3032277

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening