BEUDAMED
    FDA Adverse Event Summary report: N

    OT ULTRA2 METER

    MDR report key: 4183681 · Received October 18, 2014

    Report

    Report Number
    2939301-2014-27887
    Date Received
    October 18, 2014
    Report Date
    October 10, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 - 3/25/2015. DEVICE EVALUATION.THE LAY USER/PATIENT¿S METER AND TEST STRIPS HAVE BEEN RETURNED ON 11/19/2014 AND 1/14/2015, EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 12/10/2014 AND 1/26/2015 RESPECTIVELY WITH THE FOLLOWING FINDINGS:THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE REPRODUCED.THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA 2 METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE¿S (CCA) DOCUMENTATION AND ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) AFTER REVIEWING THE CALL RECORDING. THE PATIENT STATED THE ALLEGED ISSUE OCCURRED APPROXIMATELY 2 WEEKS PRIOR TO CONTACTING LFS. SHE ALLEGED THAT ON THE EVENING OF (B)(6) 2014 SHE OBTAINED READINGS ON THE LFS DEVICE OF ¿172, 323 AND 303MG/DL¿ AND THE FOLLOWING MORNING READINGS OF ¿52 AND 204MG/DL¿. ON BOTH OCCASIONS TESTING WAS PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE BLOOD GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR PRECISION. THE PATIENT MANAGES HER DIABETES WITH HUMALOG INSULIN (SLIDING SCALE) AND CONTINUED WITH HER USUAL DOSE OF MEDICATIONS AS PART OF HER REGULAR DIABETES MANAGEMENT ROUTINE AS A RESULT OF THIS ALLEGED PRODUCT ISSUE. SHE ADMINISTERED A HUMALOG INJECTION OF 8 UNITS ON (B)(6) 2014 AT 8AM AND 5 UNITS ON (B)(6) 2014 AT 9PM IN RESPONSE TO THE PRODUCT ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS. NO TREATMENT OR MEDICAL INTERVENTION FOR AN ACUTE DIABETES EXCURSION WAS SPECIFIED. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE CORRECT TESTING TECHNIQUE AND APPROVED SAMPLE SITE WERE USED AT THE TIME OF TESTING. THE PATIENT WAS UNABLE TO CARRY OUT A CONTROL SOLUTION TEST. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THE METER ISSUE CAUSED AND/OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663807 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3621731

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR