BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2905819 · Received January 9, 2013

    Report

    Report Number
    3008382007-2013-00563
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 30, 2012
    Report Date
    January 5, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE METER INVOLVED IN THIS CASE HAS PASSED ALL TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH HER ONETOUCH ULTRA2 TESTING IN THE SETTINGS MODE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2013 AND OBTAINED THE FOLLOWING INFORMATION. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2012. THE PATIENT MANAGES HER DIABETES WITH NOVOLOG INSULIN (MORNING AND AFTERNOON) AND LEVEMIR INSULIN (50 UNITS IN THE EVENING). THE PATIENT DENIED MAKING CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. ON THE FOLLOWING DAY, THE PATIENT CLAIMS SHE FELT SYMPTOMS OF SHAKING AND DIZZINESS. THE PATIENT ATE ½ TEASPOON OF SUGAR AS TREATMENT AND FELT BETTER ABOUT 30 MINUTES LATER. THE PATIENT DID NOT TEST HER BLOOD GLUCOSE ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA EDUCATED THE PATIENT ON THE CORRECT TESTING PROCEDURE AND WALKED THROUGH A RETEST TO RESOLVE THE ALLEGED ISSUE. 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
    11365 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3316676

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R