BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2772114 · Received October 4, 2012

    Report

    Report Number
    2939301-2012-11434
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 4, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING, THE METER'S LCD CABLE WAS FOUND TO BE BROKEN. THE TEST STRIPS WERE ALSO RETURNED. HOWEVER, TESTING WAS NOT PERFORMED SINCE THE ALLEGED ISSUE PERTAINS TO A METER ISSUE ONLY. 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) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING AN ISSUE WITH SEGMENTS MISSING ON HIS ONETOUCH ULTRA METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2012. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (TYPE NOT SPECIFIED). ALTHOUGH THE PATIENT REPORTEDLY HAD NOT TESTED SINCE THE REPORTED ISSUE BEGAN, THE PATIENT CONTINUED TO ADMINISTER HIS USUAL DOSE OF INSULIN (AMOUNT NOT SPECIFIED). AT 2AM ON (B)(6) 2012, AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMS HE FELT SYMPTOMS OF "DIFFICULTIES IN VIEW" AND RESTLESSNESS WHICH HE ASSOCIATED WITH LOW BLOOD GLUCOSE. THE PATIENT TOOK DEXTROSE AS TREATMENT AND FELT BETTER ABOUT 20 MINUTES AFTER. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO INDICATION OF MISUSE. 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R