BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7340610 · Received March 15, 2018

    Report

    Report Number
    3005862821-2018-00020
    Event Type
    Injury
    Date Received
    March 15, 2018
    Date of Event
    February 8, 2018
    Report Date
    February 13, 2018
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. OKB TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.2 A. THE CRITERIA IS <55 A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND IN HOUSE STRIPS (STRIP LOT NUMBER:D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/60 MG/DL, FOR LEVEL HIGH WERE 250/248 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~300 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. BECAUSE PATIENT DID NOT RETURN HER STRIPS, SO WE TESTED THE RETAIN STRIPS OF SAME BATCH FROM OUR WAREHOUSE (SAME AS PATIENT 'S STRIP, LOT NUMBER:D170207-1) WITH RETURNED METER AND IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/58 MG/DL; FOR LEVEL HIGH WERE 234/233 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 200~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2018 AT 5:00 PM AFTER THE END USER ALLEGED SHE RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HER PRODIGY DIABETES METER. THE END USER WAS EXPERIENCING SYMPTOMS ASSOCIATED WITH PNEUMONIA - COUGHING, WHEEZING, HEAVY BREATHING AND CHEST PAINS. THE PARAMEDICS WERE CALLED AND WHILE WAITING ON THEIR ARRIVAL A BLOOD GLUCOSE TEST WAS PERFORMED WITH HER PRODIGY DIABETES METER AND THE RESULT WAS 487 MG/DL. SUBSEQUENTLY UPON THEIR ARRIVAL THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 130 MG/DL. NO TREATMENT WAS ADMINISTERED AND THE END USER WAS TRANSPORTED TO THE ER. ONCE SHE ARRIVED TO THE ER AN ADDITIONAL BLOOD GLUCOSE TEST WAS PERFORMED WITH THE HOSPITALS METER AND THE RESULT WAS 130 MG/DL AND NO FURTHER TREATMENT WAS WARRANTED. A CHEST X-RAY WAS PERFORMED WITH CLOSE OBSERVATION. AFTER 5 HOURS IN THE ER THE END USER WAS DISCHARGED AND STATED SHE HAS AN UPCOMING APPOINTMENT WITH HER PCP AND A CARDIOLOGIST. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184523 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D170207-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention ABUDURALVITIMIN C| ALBUTEROL| BD INSULIN PEN NEEDLE - UF LANTUS| BENEFIBER| CALACLEAR LOTION| CHOLECALCIFEROL| CLOPIDOGREL| CLOTRIMAZOLE CREAM| CRANBERRY EXTRACT| DILTIAZEM| DOCUSATE SODIUM| ESCITALOPRAM OXALATE| EZETIMIBE| FLONASE| FUROSEMIDE| GABAPENTIN| HYDROCODONE| INSULIN ASPART- NOVOLOG| LAMOTRIGINE| LANTUS SOLOSTAR| LORAZEPAM| METOPROLOL SUCCINATE| MULTIVITAMIN| NITROSTAT| PANTOPRAZOLE| POTASSIUM CHLORIDE| PRO AIRFASA| RANEXA| SILVADENE| TRAMADOL| VICKS VAPORUB OINTMENT| VITIMIN C| WARFARIN