BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2842564 · Received November 21, 2012

    Report

    Report Number
    3008382007-2012-06583
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    November 18, 2012
    Report Date
    November 20, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP ((B)(4) 2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REPLACED AND REQUESTED BACK FOR INVESTIGATION. THE 510 (K) K053529.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS (B)(4) ON (B)(6) 2012 ALLEGING AN APPLY SAMPLE MESSAGE ON HIS ONE TOUCH ULTRA 2 METER. THE PATIENT MENTIONED THAT ON (B)(6) 2012 AT 3:15 PM HE TRIED TO USE THE METER WHILE HE WAS IN THE PLANE AND THE METER DISPLAYED AN APPLY SAMPLE MESSAGE AND WAS STUCK. HE CLAIMS THAT HIS SKIN STARTED TURNING GREY AND THEN STARTED TO DEVELOP VISION PROBLEMS. HE THEN DRANK SOME COKE AND FELT BETTER. ONCE HE LANDED HE HAD ANOTHER ULTRA 2 METER IN HIS CAR AND TESTED HIS BLOOD GLUCOSE USING THE SAME TEST STRIPS AND OBTAINED A 5.6 MMOL/L. WHILE TROUBLESHOOTING OVER THE PHONE IT WAS NOTED THAT THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT AND THE PATIENT WAS USING THE CORRECT TEST STRIPS. THE ALLEGED ISSUE WAS NOT RESOLVED OVER THE PHONE AND THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT HE WAS UNABLE TO TEST DUE TO THE ALLEGED ISSUE WITH THE METER, DEVELOPED SYMPTOMS, SELF-TREATED WITH (B)(4) AND FELT BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3292135

    Patients

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