BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2963988 · Received February 15, 2013

    Report

    Report Number
    3008382007-2013-03089
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE ERROR COULD NOT BE REPRODUCED (708). THE TEST STRIPS HAD RESULTS OUTSIDE THE CONTROL RANGE (190). IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. DEVICE RETURNED TO MFG DATE: METER- 2/15/2013, TEST STRIPS- 2/15/2013 A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT ON (B)(6) 2013 AND OBTAINED THE FOLLOWING INFORMATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT APPROXIMATELY 12PM. SHE TESTED ON THE SUBJECT METER AND OBSERVED A VALUE OF "139MG/DL" AS COMPARED TO A BACK UP METER WHICH GAVE A READING OF "102 MG/DL." THE PATIENT INFORMED THE MSS THAT SHE MANAGES HER DIABETES WITH DIET AND DIET ALONE AND WAS JUST RECENTLY DIAGNOSED WITH TYPE 2 DIABETES. SHE CLAIMED THAT THE FOLLOWING DAY, WHILE AT AN ADULT CENTER SHE TESTED ON THE SUBJECT METER AND REPORTED A VALUE OF ">200MG/DL" SHE STATED SHE DIDN'T HAVE ANY SYMPTOMS OF HIGH BLOOD GLUCOSE BUT THE CAREGIVERS GAVE HER PLENTY OF ICE WATER TO HELP BRING HER BLOOD GLUCOSE DOWN. APPROXIMATELY 10 MINUTES LATER, SHE CLAIMED SHE DEVELOPED SYMPTOMS OF "BLURRED VISION, SWEATING AND SHAKING." THE PATIENT STATED SHE WAS TESTED BY A CAREGIVER USING ANOTHER DEVICE (EMBRACE METER) AND A READING OF "77MG/DL." BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT WAS REPORTEDLY TREATED WITH ORANGE JUICE AND CRACKERS BY A CAREGIVER AND BEGAN TO FEEL BETTER WITHIN 20 MINUTES. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE TEST STRIPS WERE IN GOOD CONDITION, A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. 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
    67004 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3374821

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R