BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION ULTIMA METER

    MDR report key: 2211455 · Received August 9, 2011

    Report

    Report Number
    MW5021712
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    ABBOTT DIABETES CARE
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PROBLEM: POSSIBLE FALSE LOW GLUCOSE READING. PROBLEM: FAULTY INSTRUCTIONS OR MULTIPLE BOXES OF STRIPS MISSING CALIBRATOR. REGARDING RELION ULTIMA METER AND STRIPS: I HAD BEEN OCCASIONALLY TESTING MY FASTING GLUCOSE WITH RELION ULTIMA STRIPS LOT 47012 (NOT INCLUDED IN THE EARLIER RECALL) FOR SEVERAL MONTHS. LEVEL HAD BEEN GENERALLY ABOUT 90. I THEN USED A FREE SUPPLY FROM THE RECALL EARLIER IN THE YEAR, ABBOTT BRANDED PRECISION XTRA LOT 45001G185. MY FASTING LEVEL RAISED 30 POINTS CONSISTENTLY SO I PURCHASED A NEW BOX OF RELION ULTIMA STRIPS. THERE WAS NO CALIBRATOR STRIP. MY METER STILL WAS CALIBRATED FOR A SPECIFIC 5 DIGIT NUMBER FROM THE ABBOTT BRANDED BOX. I CALLED THE (B)(6) NUMBER ON THE ULTIMA BOX. THEY LOGGED THE ISSUE AND SENT ME A LARGER 100 COUNT BOX OF RELION ULTIMA STRIPS. THERE IS NO CALIBRATOR IN THIS BOX EITHER. THE PACKAGE INSERT STATES THE LOT NUMBER MUST READ 00000. IF IT DOESN'T THEN CALL THE (B)(6) NUMBER. THERE IS NO WAY TO CHANGE THE LOT NUMBER WITHOUT A CALIBRATOR. THE LATEST ONLINE MANUAL STATES THERE SHOULD BE A CALIBRATOR IN EACH BOX. THE BOX STATES "NO CODING REQUIRED," BUT THE LOT NUMBER MUST READ 00000, SO THERE IS CONFLICTING INFO. EITHER THE PACKAGE INSERT AND LATEST ONLINE MANUAL HAVE INCORRECT INFO OR THERE ARE BOXES OF STRIPS OUT THERE MISSING THE 00000 CALIBRATOR STRIP. ABBOTT RESPONDED THEY WOULD SEND ANOTHER BOX OF STRIPS AND A METER ALREADY CALIBRATED. DATES OF USE: (B)(6) 2011 - (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELION ULTIMA METER GLUCOSE METER LFR ABBOTT DIABETES CARE
    2 RELION ULTIMA STRIPS STRIPS NBW ABBOTT DIABETES CARE 47012
    3 RELION ULTIMA STRIPS STRIPS NBW ABBOTT DIABETES CARE 47448

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR