BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2880530 · Received December 19, 2012

    Report

    Report Number
    2939301-2012-13273
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    December 11, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO LIFESCAN FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE ERROR COULD NOT BE REPRODUCED. THE TEST STRIPS WERE FOUND TO HAVE A DAMAGE TEST STRIP VIAL. 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- 2/5/2013.TEST STRIPS- 1/23/2013.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) INDIA, ALLEGING THE ONETOUCH ULTRA METER IS GIVING INACCURATE HIGH READING. THE PATIENT REPORTEDLY WAS FASTING ON (B)(6) 2012 WHEN HE OBTAINED THE REPORTED ELEVATED READING ABOVE 154 MG/DL. BASED THE REPORTED HIGH READING, THE PATIENT INCREASED HIS INSULIN TO 10 UNITS OF MIXTARD INSULIN CONTRARY TO HIS DOCTOR'S RECOMMENDATION OF 6-7 UNITS. FURTHERMORE, THE PATIENT TOOK 2 MORE UNITS WHEN HIS BLOOD GLUCOSE WAS STILL BETWEEN 130-150 MG/DL. AT THE TIME OF CONCERN, THE PATIENT WAS FEELING NERVOUS AND SWEATY. WHEN HE WAS TESTED IN THE LAB LATER THAT DAY, THE PATIENT OBTAINED A BLOOD GLUCOSE READING OF 140 MG/DL ON THE SUBJECT METER AND 60 MG/DL ON THE LAB DEVICE. THE RESULTS OF THE COMPARISON WERE PERFORMED WITHIN 10 MINUTES OF EACH OTHER. ACCORDING TO THE PATIENT, HE DID NOT REQUIRE ANY HCP TREATMENT AT THE TIME OF CONCERN. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT TOOK INSULIN BASED ON THE LFS METER READING AND HAD SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA. IN ADDITION, THE METER TO LAB COMPARISON WAS OUTSIDE THE LIFESCAN'S CRITERIA FOR ACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening