BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 3801611 · Received May 9, 2014

    Report

    Report Number
    2939301-2014-10753
    Event Type
    Injury
    Date Received
    May 9, 2014
    Report Date
    May 5, 2014
    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
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2014, THE LAY-USER/REPORTER CONTACTED LIFESCAN (LFS) (B)(4) ON BEHALF OF THE LAY-USER/PATIENT, ALLEGING THAT ONETOUCH ULTRA METER IS GIVING INACCURATE HIGH READINGS OF ¿262 AND 222 MG/DL.¿ THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT MANAGES HER DIABETES WITH UNSPECIFIED INSULIN. SHE USED A SLIDING SCALE INSULIN REGIMEN BASED ON HER BLOOD GLUCOSE READINGS. REPORTEDLY, HER LFS BLOOD GLUCOSE READINGS HAVE BEEN ELEVATED SINCE (B)(6) 2014. THE PATIENT FELT THAT SHE HAS BEEN TAKING INSULIN BASED ON INACCURATE HIGH READINGS. DUE TO THE ALLEGED ISSUE, THE PATIENT WAKES UP IN THE MORNING WITH SYMPTOM DESCRIBED AS ¿SHAKY¿ FOR ONE WEEK. DURING TROUBLESHOOTING, THE PATIENT CONFIRMED THE ALLEGED READINGS OF ¿262 AND 222 MG/DL¿ WERE PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE UNIT OF MEASUREMENT WAS CORRECTLY SET. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD SYMPTOM SUGGESTIVE OF HYPOGLYCEMIA AFTER SHE TOOK INSULIN BASED ON THE LFS ELEVATED METER READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280716 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3592238

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening