BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2876856 · Received December 17, 2012

    Report

    Report Number
    3008382007-2012-08421
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 4, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER WAS DISPLAYING AN INACCURATELY HIGH RESULT COMPARED THE SAME METER AS WELL AS TO HER FEELINGS OR NORMAL RESULTS. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO FOLLOW UP WITH THE PATIENT FOR ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2012, BETWEEN 9-10PM, THE ALLEGED ISSUE FIRST STARTED. THE PATIENT ALLEGED OBTAINING READINGS OF "85, 87, 200, 464 AND 600MG/DL" ON THE LFS METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE READINGS EXCEEDS THE EXPECTED RESULT OF <=20% OR <=20MG/DL OBTAINED WITHIN 20 MINUTES OF EACH OTHER. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANAGE HER DIABETES. THE PATIENT REPORTED TAKING HER USUAL 30 UNITS OF HUMALOG INSULIN ON (B)(6) 2012 AT 9PM. THE PATIENT REPORTED 1.5 TO 2 HOURS LATER, SHE FELT SYMPTOMS OF "LOW BLOOD GLUCOSE." THE PATIENT REPORTED ON (B)(6) 2012 AFTER MIDNIGHT, SHE HAD SOMETHING TO EAT OR DRINK AS TREATMENT TO HER SYMPTOMS. THE PATIENT REPORTED ON (B)(6) 2012 AFTER MIDNIGHT, SHE OBTAINED A READING OF "86MG/DL" ON ANOTHER UNKNOWN DEVICE FOLLOWING TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING. THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION AND SHE WAS USING THE SAME APPROVED SAMPLE SITE FOR TESTING. THE PATIENT WAS REPORTEDLY USING THE CORRECT TESTING PROCESS AND THE TEST STRIP VIAL WAS IN GOOD CONDITION. A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING ANY CONTROL SOLUTION AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE, SHE ADMINISTERED HER USUAL DOSE OF MEDICATION, DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED SELF TREATMENT TO PREVENT FURTHER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3334418

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening| R