BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2895027 · Received January 3, 2013

    Report

    Report Number
    3008382007-2013-00019
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 19, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A CAPACITOR FAILURE. 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) ALLEGING HER ONETOUCH ULTRA2 METER WAS DISPLAYING A BATTERY INDICATOR WHEN ATTEMPTING TO PERFORM A BLOOD TEST. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2012 AT AN UNSPECIFIED TIME. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH LANTUS INSULIN (80U AT NIGHT) AND NOVOLOG INSULIN (13U IN THE MORNING, 8U AT LUNCH AND 23U AT DINNER). SHE CLAIMED ON THE SAME DAY AFTER ATTEMPTING TO TEST WITH THE SUBJECT DEVICE, SHE DEVELOPED SYMPTOMS OF "FEELING FUNNY AND SHAKY" AT AN UNKNOWN TIME. SHE ALSO ALLEGED THAT THIS OCCURRED AGAIN ON (B)(6) 2012, AT AN UNKNOWN TIME AND STATED THAT SHE SKIPPED HER NOVOLOG INSULIN DOSE IN RESPONSE TO NOT BEING ABLE TO TEST ON THIS DAY. THE PATIENT REPORTEDLY SELF-TREATED WITH FOOD/DRINK ON (B)(6) 2012 AS WELL AS ON (B)(6) 2012. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT DEVICE WAS NOT BRAND NEW. THE PATIENT WAS USING THE CORRECT TEST STRIPS. BASED ON THE AGE OF THE METER/BATTERY, A BATTERY REPLACEMENT WAS NOT YET REQUIRED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3180 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3365816

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R