BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 3010098 · Received March 19, 2013

    Report

    Report Number
    3008382007-2013-05560
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    February 25, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (03/18/2013)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(6) 2013 WITH THE FOLLOWING FINDINGS: THE METER PASSED TESTING, THE COMPLAINT WAS NOT REPRODUCIBLE. THE EVALUATION OF THE TEST STRIPS HAS NOT YET BEEN COMPLETED THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A SECOND FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA METER WAS READING INACCURATELY COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION AS WELL AS ADDITIONAL INFORMATION OBTAINED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) DURING A FOLLOW UP CALL WITH THE PATIENT ON (B)(6) 2013. THE PATIENT REPORTED, THE EVENING BEFORE CONTACTING LFS, HE TESTED ON THE LFS METER AND OBTAINED READINGS OF "90 AND 130MG/DL" ON DIFFERENT HANDS. THE PATIENT REPORTED USING ORAL MEDICATIONS WITH DIET AND EXERCISE TO MANAGE HIS DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HIS USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED THE NEXT MORNING, HE WOKE UP AND TRIED TO STAND UP, "GOT DIZZY" AND SAT DOWN ON THE BED AND "PASSED OUT." THE PATIENT REPORTED HIS ROOMMATE AND BROTHER WERE IN HIS HOME. THE PATIENT REPORTED HIS BROTHER CALLED EMERGENCY MEDICAL SERVICES (EMS) AND HE WAS TRANSPORTED TO THE HOSPITAL EMERGENCY ROOM (ER). THE PATIENT WAS UNABLE TO RECALL WHAT TREATMENTS HE WAS GIVEN EN ROUTE TO THE ER OR WHILE AT THE HOSPITAL. THE PATIENT REPORTED A BLOOD GLUCOSE READING OF "46MG/DL" WAS OBTAINED AT AN UNKNOWN TIME ON AN UNKNOWN METER. THE PATIENT REPORTED HE WAS ADMITTED AT THE HOSPITAL FOR 2 DAYS AND WAS TREATED FOR HYPOGLYCEMIA. THE PATIENT REPORTED, HE ALSO SUFFERS FROM A BRAIN ANEURYSM. DURING THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND HE WAS USING AN APPROVED SAMPLE SITE TO OBTAIN THE SAMPLES. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE METER INVOLVED IN THIS COMPLAINT HAS BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2013 WITH THE FOLLOWING FINDINGS: THE COMPLAINT WAS NOT REPRODUCIBLE. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS, DUE TO THE ALLEGED ISSUE, HE DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114353 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3364713

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R