BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2990847 · Received March 5, 2013

    Report

    Report Number
    3008382007-2013-04278
    Event Type
    Injury
    Date Received
    March 5, 2013
    Report Date
    February 17, 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
    PATIENT

    Narratives

    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, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH THE PATIENT'S ONETOUCH ULTRA2 METER TESTING IN THE SETTINGS MODE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE REPORTER ON (B)(6) 2013 AND OBTAINED THE FOLLOWING INFORMATION. THE ALLEGED ISSUE BEGAN IN (B)(6) 2013. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATIONS (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS USUAL DOSE OF MEDICATIONS; HOWEVER, THE PATIENT ALLEGEDLY WAS NOT TESTING HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE. ABOUT A WEEK AFTER, THE REPORTER CLAIMS THE PATIENT FELL AND "BLACKED OUT." THE PATIENT WAS DISCOVERED BY HIS GRANDSON. THE PATIENT'S GRANDSON PICKED THE PATIENT UP AND BROUGHT HIM TO THE PORCH PATIO. THE PATIENT REPORTEDLY SLOWLY REGAINED CONSCIOUSNESS WITH THE FRESH OUTDOOR AIR. WITHIN A FEW MINUTES LATER, EMERGENCY MEDICAL SERVICES (EMS) ARRIVED AND TOOK THE PATIENT'S VITAL SIGNS. THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "125 MG/DL" WITH THE EMS METER. THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE ADDITIONAL TESTING WAS PERFORMED. IT IS NOT CLEAR WHAT MAY HAVE CAUSED THE PATIENT TO "BLACK OUT;" HOWEVER, THE REPORTER WAS INFORMED THE PATIENT HAS AN IRREGULAR HEARTBEAT. THE REPORTER DENIED THE PATIENT RECEIVED ANY ADDITIONAL TREATMENT. THE CCA EDUCATED THE REPORTER 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 "BLACKED OUT" AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93893 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3361988

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening