BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT VERIO PRO METER

    MDR report key: 2880748 · Received December 20, 2012

    Report

    Report Number
    3008382007-2012-08719
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    December 11, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) BELGIUM ALLEGING A PATIENT'S ONETOUCH VERIOPRO METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER CARE ADVOCATE (CCA) DURING A FOLLOW-UP CALL. THE PATIENT TESTS HIS BLOOD GLUCOSE 3-4X DAILY. THE PATIENT MANAGES HIS DIABETES WITH NOVORAPID INSULIN (2 UNITS PER CARBOHYDRATE) AND LANTUS INSULIN (30 UNITS). THE ALLEGED ISSUE BEGAN ONE MORNING IN (B)(6) 2012. IT WAS REPORTED, THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF "88 MG/DL" WITH THE SUBJECT METER AND "30 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. IMMEDIATELY PRIOR TO TESTING, THE REPORTER CLAIMS THE PATIENT "FELT POWERLESS" WHICH THE PATIENT ASSOCIATED WITH LOW BLOOD GLUCOSE. THE PATIENT DRANK A SPORTS DRINK AS TREATMENT. A FEW DAYS PRIOR TO THE ALLEGED ISSUE, THE PATIENT REPORTEDLY LOWERED HIS USUAL DOSE OF LANTUS INSULIN. PREVIOUS BLOOD GLUCOSE RESULTS WERE NOT PROVIDED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "30 MG/DL" WITH ANOTHER DEVICE WHICH IS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3230779

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R