BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2220711 · Received August 23, 2011

    Report

    Report Number
    2939301-2011-07902
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS NOT PROVIDED. THE 510 (K) # IS K061118.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL # 1 ADDITIONAL INFORMATION IN REGARDS TO THE PRODUCTS BEING RETURNED TO LFS FOR INVESTIGATION. (B)(6) 2011 THE PRODUCTS WERE RETURNED WITH THE FOLLOWING FINDINGS: TEST STRIPS DID NOT NEED TO BE TESTED SINCE THE ALLEGED ISSUE IS WITH THE METER. THE METER WAS RETURNED AND TESTED AND THE METER PASSED TESTING. THE ALLEGED ISSUE WITH THE PRODUCT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2011 ALLEGING A BATTERY INDICATOR ON THEIR ONE TOUCH ULTRA MINI METER. THE PATIENT MENTIONED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT AROUND 1:30PM. DUE TO THE ALLEGED ISSUE, THE PATIENT DID NOT TAKE ANY ACTION. APPROXIMATELY 30 MINUTES LATER, THE PATIENT HAD DEVELOPED SYMPTOMS OF BLURRY VISION AND FEELING WEAK. THE PATIENT DID NOT ATTEMPT TO TEST ON ANOTHER DEVICE AND SELF-TREATED WITH FOOD /DRINK. THE PATIENT DID NOT SEEK ANY FURTHER MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THIS IS NOT THE FIRST TIME THE PRODUCT IS BEING USED. THE PATIENT DENIED ANY MISUSE OF THE PRODUCT. THE BATTERIES DID NOT NEED TO BE REPLACED BASED ON THE INITIAL CALL WITH THE CUSTOMER CARE ADVOCATE (CCA). THE PRODUCT WAS REPLACED AND REQUESTED BACK. THE METER WAS RETURNED AND IT WAS NOTED THAT THE METER HAD PASSED TESTING AND THE ALLEGED ISSUE WAS NOT CONFIRMED. THE TEST STRIPS WERE ALSO RETURNED; HOWEVER, NOT TESTED SINCE THE ALLEGED ISSUE IS WITH THE METER AND NOT WITH THE TEST STRIPS. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE BATTERY INDICTOR, THEY WERE UNABLE TO TEST AND LATER DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY BASED ON LFS DEFINITION AND HAD TO SELF-TREAT WITH FOOD/DRINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3159976

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R