BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6259255 · Received January 17, 2017

    Report

    Report Number
    3005862821-2017-00009
    Event Type
    Injury
    Date Received
    January 17, 2017
    Date of Event
    December 15, 2016
    Report Date
    December 15, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 1.0UA. 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:D150110-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 64/66 MG/DL, FOR LEVEL HIGH ARE 275/271 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; THE STRIP LOT #D150110-2 WAS MANUFACTURED ON 01/10/2015 AND EXPIRED IN 01/10/2017. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2016 AT 7:30 AM AFTER THE END USER COULD NOT BE AWAKEN FROM HER SLEEP. AT THAT MOMENT A BLOOD GLUCOSE TEST WAS PERFORMED WITH THE PRODIGY METER WITH A RESULT OF 81 MG/DL. THE PARAMEDICS WERE CALLED AND PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND RECEIVED A RESULT OF 42 MG/DL. THE END USER WAS TRANSPORTED TO THE ER AND COULD NOT REMEMBER WHAT TREATMENT WAS ADMINISTERED TO ASSIST WITH STABILIZING HER BLOOD GLUCOSE LEVELS. UPON DISCHARGE THE END USER WAS INSTRUCTED TO DECREASE HER LEVEMIR TO 5 UNITS AND EAT A SNACK BEFORE BED. NO ADDITIONAL INFORMATION WAS PROVIDED AS IT RELATES TO THE MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41353 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 54800 - D150110-2

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention AMLODIPINE| ASPIRIN| BUMETANIDE| CALCITRIOL| CITALOPRAM| GABAPENTIN| HYDRALAZINE| HYDROCODONE| IRON| ISOSORBIDE| LEVEMIR E. INITIAL| NOVOLOG| OMEGA 3| PRAVASTATIN| VITAMIN D3