BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2461125 · Received February 17, 2012

    Report

    Report Number
    2939301-2012-01684
    Event Type
    Injury
    Date Received
    February 17, 2012
    Date of Event
    February 8, 2012
    Report Date
    February 9, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. THE 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO FEELING/NORMAL RESULT(S). THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE TO THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS ON (B)(6) 2012 AND OBTAINED/VERIFIED THE FOLLOWING INFORMATION. THE PATIENT INFORMED THE MSS THAT HIS TESTING FREQUENCY IS 8X DAILY AND MANAGES HIS DIABETES WITH NOVOLOG (SLIDING SCALE) AND LANTUS (22 UNITS AT NIGHT) INSULIN. THE PATIENT REPORTED HE OBTAINED ALLEGED HIGH READINGS OF "364 AND 400 MG/DL" WITH THE SUBJECT METER THAT BEGAN ON (B)(6) 2012 AT 6:00PM. DUE TO THE ALLEGED HIGH READINGS, THE PATIENT CONFIRMED HE ADMINISTERED 12 UNITS OF NOVOLOG; WHICH HE STATED MIGHT HAVE BEEN TOO MUCH. THE PATIENT CONFIRMED HAVING LOW BLOOD SUGAR SYMPTOMS OF IRRITABILITY, SWEATY, SHAKY, AND INCOHERENT AFTER THE ALLEGED ISSUE BEGAN. IN RESPONSE TO HIS SYMPTOMS, THE PATIENT STATED HE TREATED HIMSELF WITH A GLASS OF ORANGE JUICE AND A SLICE OF BREAD WITH PEANUT BUTTER. AFTER THE TREATMENT, THE PATIENT CONFIRMED HE FELT BETTER INSTANTLY. THE PATIENT ALSO STATED HE TESTED ON ANOTHER DEVICE ((B)(4)) AND OBTAINED GLUCOSE READINGS OF "180, 195, AND 195 MG/DL". AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY AT THE TIME OF TESTING; HOWEVER THE PATIENT WAS USING EXPIRED TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT STATED HE OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2859680

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R