BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2896900 · Received January 4, 2013

    Report

    Report Number
    3008382007-2013-00059
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    November 22, 2012
    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

    FOLLOW-UP # 1 ((B)(6) 2013): ON (B)(6) 2013, THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT AND OBTAINED ADDITIONAL INFORMATION REGARDING THIS COMPLAINT. AT THE END OF (B)(6) 2012, THE PATIENT CONFIRMED THE CONTROL SOLUTION TESTED OUTSIDE OF SPECIFICATIONS WITH THE SUBJECT METER. THE PATIENT DID NOT DEVELOP SYMPTOMS OR RECEIVE MEDICAL TREATMENT DUE TO THE FAILING CONTROL SOLUTION TEST RESULTS. A WEEK PRIOR TO TESTING WITH THE CONTROL SOLUTION, THE PATIENT REPORTEDLY "PASSED OUT" DUE TO INCREASING HIS INSULIN BASED ON AN ALLEGED BLOOD GLUCOSE RESULT OF "308 MG/DL." AT THAT TIME, THE PATIENT WAS TAKEN TO THE HOSPITAL AND "WOKE UP WITH TUBES ALL OVER." THE PATIENT COULD NOT FIRM RESULTS OBTAINED WITH THE HOSPITAL METER. BASED ON THE ADDITIONAL INFORMATION OBTAINED, THERE IS NO INDICATION THAT THE REPORTED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S SYMPTOMS AND TREATMENT OCCURRED PRIOR TO THE REPORTED ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION (NOT AN ADVERSE EVENT AS ORIGINALLY REPORTED ON (B)(6) 2013) DUE TO THE FAILING CONTROL SOLUTION TEST RESULT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE CONTROL SOLUTION READ OUTSIDE OF SPECIFICATIONS ON HIS ONETOUCH ULTRA2 METER. 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. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2012. 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 CORRECT CONTROL SOLUTION WAS BEING USED FOR TESTING AND THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. A CONTROL SOLUTION TEST WAS PERFORMED WHICH TESTED OUTSIDE OF SPECIFICATIONS. BASED ON THE PROVIDED INFORMATION AT THIS TIME, IT IS UNCLEAR HOW THE INACCURACY ISSUE WITH CONTROL SOLUTION CAN LEAD TO THE PATIENT'S SYMPTOM. THUS, THE LINKAGE BETWEEN THE REPORTED PRODUCT ISSUE AND THE ALLEGED INJURY BY THE PATIENT REMAINS UNCLEAR. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY "PASSED OUT" AFTER THE ALLEGED ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4564 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