BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2895900 · Received January 4, 2013

    Report

    Report Number
    3008382007-2013-00055
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    December 18, 2012
    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
    AZ, 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) 2012, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA2 METER CONTINUED TO DISPLAY THE APPLY SAMPLE MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE REPORTER ON (B)(4) 2013 AND OBTAINED THE FOLLOWING INFORMATION. THE ALLEGED ISSUE BEGAN ABOUT A MONTH PRIOR TO CONTACTING LFS. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). THE REPORTER DID NOT SPECIFY IF THE PATIENT MADE CHANGES TO HIS USUAL DOSE OF MEDICATIONS; HOWEVER, ALLEGED THE PATIENT DISCONTINUED TESTING HIS BLOOD GLUCOSE. AFTER THE START OF THE ALLEGED ISSUE, THE REPORTER CLAIMS THE PATIENT HAD SYMPTOMS OF SLURRED SPEECH AND DIZZINESS BEFORE PASSING OUT. EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED. THE REPORTER COULD NOT SPECIFY RESULTS OBTAINED WITH THE EMS METER OR TREATMENT PROVIDED. THE PATIENT WAS TAKEN TO THE HOSPITAL AND ADMITTED FOR 2 DAYS FOR OBSERVATION. THE REPORTER HAS SINCE CONTINUED TESTING THE PATIENT WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE CORRECT TEST STRIPS WERE BEING USED FOR TESTING. THE CCA WAS NOT ABLE TO WALK THE REPORTER THROUGH A RETEST TO RESOLVE THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND 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
    4259 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3199133

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R