BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRA2 METER

    MDR report key: 4242811 · Received November 11, 2014

    Report

    Report Number
    2939301-2014-30265
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    November 6, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN USA ALLEGING THAT HER ULTRA2 METER READ INACCURATELY LOW. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED FROM THE PATIENT DURING A FOLLOW-UP TELEPHONE CALL. THE PATIENT STATED THAT THE ALLEGED INACCURACY BEGAN ON (B)(6) 2014 (TIME UNKNOWN). THE PATIENT STATED THAT SHE OPENED A NEW VIAL OF TEST STRIPS AND PERFORMED 5 CONTROL SOLUTION READINGS, ALL OF WHICH WERE IN THE RANGE OF "112-116 MG/DL" COMPARED TO THE TEST STRIP VIAL CONTROL SOLUTION RANGE OF "117-156 MG/DL". THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATIONS WITH DIET AND/OR EXERCISE. THE PATIENT CONFIRMED THAT SHE DID NOT MAKE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ALLEGED PRODUCT ISSUE; HOWEVER SHE HAS BEEN INCREASING HER FLUID INTAKE AND EXERCISE DUE TO PROGRESSIVELY HIGHER BLOOD GLUCOSE READINGS OVER THE LAST FEW WEEKS THAT SHE ASSOCIATED WITH GENERAL DIABETES PROGRESSION RATHER THAN THE ALLEGED INACCURACY. THE PATIENT CLAIMED TO HAVE DEVELOPED THE SYMPTOM OF "BLURRED VISION" "ABOUT 5 DAYS" AFTER THE ALLEGED INACCURACY BEGAN. THE PATIENT ASSOCIATED THIS SYMPTOM WITH "GENERALLY INCREASING" BLOOD GLUCOSE AND NOT DUE TO THE ALLEGED INACCURACY. THE PATIENT DENIED HAVING RECEIVED ANY TREATMENT. THE PATIENT STATED THAT SHE OPENED ANOTHER VIAL WITH THE SAME LOT NUMBER AS THE SUBJECT TEST STRIPS AND OBTAINED CONTROL SOLUTION READINGS THAT WERE WITHIN THE TEST STRIP CONTROL SOLUTION RANGE. AT THE TIME OF INITIAL TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT WAS USING THE CORRECT CONTROL SOLUTION, THE PATIENT WAS USING THE CORRECT TESTING TECHNIQUE, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, THE TEST STRIPS HAD NOT EXPIRED OR BEEN OPEN FOR LONGER THAN THE DISCARD DATE, THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN, THE TEST STRIPS WERE NOT IDENTIFIED AS COUNTERFEIT AND THE CONTROL SOLUTION HAD NOT EXPIRED OR BEEN OPEN FOR LONGER THAN THE DISCARD DATE. THE CSR PERFORMED A WALK-THROUGH CONTROL SOLUTION TEST WITH A DIFFERENT VIAL OF TEST STRIPS AND THE RESULT WAS IN RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION(S): ALTHOUGH THE PATIENT DEVELOPED A SYMPTOM SUGGESTIVE OF A SEVERE HIGH BLOOD GLUCOSE EXCURSION, THERE WAS NO ALLEGATION THAT THE SUBJECT METER OR TEST STRIPS CAUSED OR CONTRIBUTED; RATHER THE SYMPTOM WAS ASSOCIATED WITH GENERALLY INCREASING BLOOD GLUCOSE EXPERIENCED OVER THE LAST FEW WEEKS DUE TO DIABETES PROGRESSION. THE ISSUE WAS RESOLVED WITH A DIFFERENT VIAL OF TEST STRIPS DURING TROUBLESHOOTING; HOWEVER A MALFUNCTION WITH THE SUBJECT TEST STRIPS CANNOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725164 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3687935

    Patients

    Seq Age Sex Outcome Treatment
    1