BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2220360 · Received August 23, 2011

    Report

    Report Number
    2939301-2011-07853
    Event Type
    Injury
    Date Received
    August 23, 2011
    Report Date
    August 8, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S PRODUCT HAS BEEN RETURNED AND EVALUATED BY LFS PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS NOT PASSED ALL TESTING. THE 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT'S RELATIVE CONTACTED LIFESCAN (LFS) TO REPORT THE PATIENT EXPERIENCING A POWER ISSUE WITH HER ONE TOUCH ULTRAMINI METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER PREMATURELY SHUTTING OFF DURING USE BEGAN APPROXIMATELY 6 MONTHS PRIOR TO CONTACTING LFS. SHE REPORTED THAT THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER) AND APPROXIMATELY 3 WEEKS PRIOR TO CONTACTING LFS, THE PATIENT INCREASED HER FOOD AND DRINK INTAKE. THE REPORTER CLAIMED AFTER THE ALLEGED ISSUE STARTED, APPROXIMATELY 3 WEEKS BEFORE CONTACTING LFS, THE PATIENT FELT SWEATY, HAD A GARGLING SOUND OF THE VOICE, WAS NOT RESPONDING, AND BECOME BELLIGERENT. REPORTEDLY, ALSO APPROXIMATELY 3 WEEKS BEFORE CONTACTING LFS, THE PATIENT SELF TREATED WITH 6U OF LANTUS AND 2 SHOTS OF HUMALOG. NO OTHER DEVICE WAS AVAILABLE AT THE TIME OF CONCERN. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE CCA NOTED THAT THE METER WAS NOT DUE FOR A BATTERY REPLACEMENT AND THERE WAS NO INFORMATION OF MISUSE OF THE DEVICE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE METER INVOLVED IN THIS CASE HAS NOT PASSED ALL TESTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S REPORTER CLAIMS THE PATIENT WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY WHICH REQUIRED INTERVENTION AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3112624

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening| R