BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2895908 · Received January 4, 2013

    Report

    Report Number
    3008382007-2013-00067
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    December 20, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 2013, THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT AND OBTAINED ADDITIONAL INFORMATION REGARDING THIS COMPLAINT. ON THE AFTERNOON OF (B)(6) 2012, THE PATIENT REPORTED OBTAINING A BLOOD GLUCOSE RESULT OF ''308 MG/DL'' WITH THE SUBJECT METER. BASED ON THE ALLEGED RESULT, THE PATIENT ADMINISTERED SELF 22 UNITS INSULIN. THE PATIENT REPORTEDLY FELT HE MAY HAVE TAKEN TOO MUCH INSULIN BECAUSE HE CLAIMS HE PASSED OUT SHORTLY AFTER. THE PATIENT'S WIFE AND SON FOUND THE PATIENT AND CONTACTED EMERGENCY MEDICAL SERVICES (EMS). THE PATIENT COULD NOT CONFIRM RESULTS OBTAINED WITH THE EMS METER; HOWEVER, WAS ADVISED HIS BLOOD SUGAR WAS LOW. THE PATIENT WAS TAKEN TO THE HOSPITAL AND "WOKE UP WITH TUBES ALL OVER." THE PATIENT WAS DISCHARGED FROM THE HOSPITAL LATER THAT SAME DAY.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA2 METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS/ NORMAL BLOOD GLUCOSE RESULTS AND COMPARED TO ANOTHER DEVICE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. IT IS NOT CLEAR WHEN THE ALLEGED ISSUE BEGAN. THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT 'OVER 300 MG/DL' WITH THE SUBJECT METER; HOWEVER, DID NOT PROVIDE RESULTS OBTAINED WITH THE OTHER DEVICE. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE. A COUPLE HOURS AFTER THE ALLEGED ISSUE, THE PATIENT CLAIMS HE 'PASSED OUT.' THE PATIENT REPORTEDLY WAS TAKEN TO THE EMERGENCY ROOM (ER). IT IS NOT KNOWN WHAT THE PATIENT'S BLOOD GLUCOSE READ ON THE ER METER. THE PATIENT ALLEGED HIS SYSTEM WAS 'FLUSHED OUT' AT THAT TIME. ADDITIONAL TREATMENT WAS NOT SPECIFIED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. A CONTROL SOLUTION TEST WAS PERFORMED WHICH TESTED OUTSIDE OF SPECIFICATIONS. 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
    4394 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3350009

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R