BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6043075 · Received October 20, 2016

    Report

    Report Number
    3005862821-2016-00089
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    September 21, 2016
    Report Date
    September 21, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. THE STANDBY CURRENT TEST IS 12.5UA. THE CRITERIA IS <55UA. PASS; METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK; TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETAIN STRIPS (STRIP LOT NUMBER:D6151130-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 60/65 MG/DL, FOR LEVEL HIGH ARE 280/277 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS; TESTED THE RETURNED STRIPS FROM PATIENTS (STRIP LOT NUMBER:D6151130-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 67/65 MG/DL; FOR LEVEL HIGH WERE 272/278 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS

    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
    695270 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51900 D6151130-1

    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