BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTO CODE

    MDR report key: 5990680 · Received September 30, 2016

    Report

    Report Number
    3008789114-2016-00085
    Event Type
    Injury
    Date Received
    September 30, 2016
    Date of Event
    September 21, 2016
    Report Date
    September 21, 2016
    Manufacturer
    OK BIOTECH COMPANY LTD
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    END USER REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2016 AT 1:45 PM AFTER HAVING CONTINOUS HIGH GLUCOSE READINGS (200 - 263 MG/DL) FROM THE PRODIGY METER. THE END USER VISITED THE ER AND COULD NOT RECALL HER BLOOD GLUCOSE READING UPON ARRIVAL. NO INFORMATION WAS PROVIDED IN REGARDS TO TREATMENT ADMINISTERED TO LOWER HER BLOOD GLUCOSE. THE ER DOCTOR INSTRUCTED THE END USER TO FOLLOW UP WITH HER PCP AND TO PURCHASE ANOTHER METER BECAUSE OF THE HIGH READINGS. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643022 PRODIGY AUTO CODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH COMPANY LTD 51900

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention ACEPRIL 10MG 1 A DAY| DULOXETINE 60MG 1A DAY| GABAPENTIN 100MG 1 A DAY| LEVEMIR 60UNITS 1 A DAY| NAPROXEN 375MG AS NEEDED