BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2650686 · Received July 11, 2012

    Report

    Report Number
    2939301-2012-07655
    Event Type
    Injury
    Date Received
    July 11, 2012
    Date of Event
    June 6, 2012
    Report Date
    June 22, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012 - DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ((B)(4) 2012) WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A COMMUNITY HEALTH WORKER (CHW) CONTACTED LIFESCAN (LFS) ON BEHALF OF THE LAY USER/PATIENT ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST WAS UNABLE TO GET IN TOUCH WITH THE PATIENT AND SO THE COMPLAINT WAS CLASSIFIED BASED ON THE INFORMATION OBTAINED BY THE CUSTOMER CARE ADVOCATE (CCA). THE CHW WAS NOT SURE WHEN THE ALLEGED ISSUE STARTED. THE CHW CLAIMED THAT A BLOOD GLUCOSE RESULT OF "219 MG/DL" WAS OBTAINED ON THE SUBJECT METER WHICH SHE WAS COMPARING TO A RESULT OF "200 MG/DL" OBTAINED ON A HOSPITAL (UNKNOWN AMOUNT OF PASSED TIME BETWEEN RESULTS). BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT REPORTEDLY MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER) AND THE CHW DENIED THAT THE PATIENT MADE ANY CHANGES TO HER NORMAL DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. THE CHW MENTIONED THAT THE PATIENT WAS ADMINISTERED HER NORMAL 44 UNIT DOSE OF INSULIN AT 8 A.M. ON (B)(6) 2012 AND THEN APPROXIMATELY 3-4 HOURS LATER DEVELOPED "A HEADACHE AND DIZZINESS" BEFORE SHE "PASSED OUT." WHEN EMERGENCY MEDICAL SERVICES (EMS) ARRIVED AT 12 P.M. ON (B)(6) 2012, THEY REPORTEDLY TESTED THE PATIENT'S BLOOD GLUCOSE AND OBTAINED A RESULT ON THEIR METER OF "67 OR 51 MG/DL" THE CHW INFORMED THE CCA THAT EMS ADMINISTERED THE PATIENT INSULIN (UNKNOWN DOSE) AT 12 P.M. ON (B)(6) 2012. DURING TROUBLESHOOTING THE CHW DID NOT HAVE CONTROL SOLUTION. THE CCA CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND THAT THE PATIENT WAS USING GOOD/UNEXPIRED TEST STRIPS. REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT REPORTEDLY PASSED OUT AS A RESULT OF THE ALLEGED ISSUE. IN ADDITION, EMS TESTED THE PATIENT'S BLOOD GLUCOSE AND REPORTEDLY OBTAINED A BLOOD GLUCOSE READING SUGGESTIVE OF A SERIOUS INJURY THAT LED THEM TO TRANSPORTING THE PATIENT TO THE ER FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3276915

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R