BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2991672 · Received March 6, 2013

    Report

    Report Number
    3008382007-2013-04281
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 12, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS/HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2013 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. 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 THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH. ON (B)(6) 2013, THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE REPORTER TO OBTAIN AND VERIFY INFORMATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN APPROXIMATELY TWO WEEKS PRIOR TO CONTACTING LFS FOR ASSISTANCE. PRIOR TO TESTING, SHE REPORTEDLY WAS EXPERIENCING SYMPTOMS OF "SWEATING AND WEAKNESS" WHICH SHE ASSOCIATED WITH LOW BLOOD GLUCOSE. SHE STATED HER NEIGHBOR CONTACTED EMERGENCY MEDICAL SERVICES (EMS) AT AN UNKNOWN TIME. WHEN THEY ARRIVED THEY TESTED HER BLOOD GLUCOSE USING AN EMS DEVICE AND OBSERVED A READING OF "40MG/DL." THE PATIENT INITIALLY CLAIMED THAT SHE HAD CHECKED HER BLOOD GLUCOSE USING THE SUBJECT METER AFTER THE ONSET OF HER SYMPTOMS AND OBSERVED A VALUE OF "83MG/DL" AND WITHIN 30 MINUTES THE TEST ON THE EMT DEVICE WAS PERFORMED. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% AND/ OR <=30 MG/DL. NO PRIOR BLOOD GLUCOSE VALUES TAKEN ON THAT DAY WERE PROVIDED. THE PATIENT MANAGES HER DIABETES WITH 2 METFORMIN PILLS 500MG AND 2 GLYBURIDE PILLS TWICE PER DAY AND REPORTED THAT SHE INCREASED HER FOOD/DRINK INTAKE IN RESPONSE TO THE SYMPTOMS AT AN UNKNOWN TIME. THE PATIENT WAS REPORTEDLY TREATED BY THE PARAMEDICS WITH GLUCOSE TABLETS AND A SLICE OF BREAD WITH PEANUT BUTTER AND FELT BETTER WITHIN 20 MINUTES. THE EMS LEFT ONCE THE PATIENT WAS FEELING BETTER. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SUBJECT TEST STRIPS WERE STORED CORRECTLY AND IN GOOD CONDITION, A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE, THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. ALTHOUGH THE PATIENT WAS SYMPTOMATIC PRIOR TO OBTAINING THE ALLEGED HIGH READING ON THE SUBJECT METER, THIS COMPLAINT IS BEING REPORTED DUE TO POSSIBLE DELAY IN TREATMENT SINCE THE PATIENT REQUIRED MEDICAL INTERVENTION FROM AN HCP AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95949 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3319253

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R