BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6351989 · Received February 23, 2017

    Report

    Report Number
    3005862821-2017-00019
    Event Type
    Injury
    Date Received
    February 23, 2017
    Date of Event
    January 25, 2017
    Report Date
    January 25, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE AND STRIP WERE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE RETURNED PRODUCTS ARE ALL OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF THE RETURNED METER, THE RESULT WAS 17.1 A. THE CRITERIA IS <55 A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION WERE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER:D6160617-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 58/52 MG/DL, FOR LEVEL HIGH WERE 257/256 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . WE TESTED THE RETAIN STRIPS OF SAME BATCH (STRIP LOT NUMBER:D6160617-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/65 MG/DL; FOR LEVEL HIGH WERE 258/260 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Additional Manufacturer Narrative · 1

    BECAUSE DEVICE WAS NOT RETURNED TO OK BIOTECH, THEREFORE, WE WERE UNABLE TO PERFORM FURTHER TESTING ON THE SUSPECTED DEVICE. OK BIOTECH REVIEWED THE MANUFACTURING RECORD OF THIS SUSPECTED DEVICE (METER SERIAL NUMBER # (B)(4)), AND THE METER WAS QUALIFIED AND RELEASED BY THE QUALITY CONTROL DEPARTMENT AND SHIPPED TO (B)(4) ON 11/30/2016. THE STRIP LOT #D6160617-1 WAS MANUFACTURED ON 06/17/2016 AND EXPIRED IN JUNE 2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE TESTED THE RETAIN STRIPS OF SAME BATCH. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/65 MG/DL; FOR LEVEL HIGH WERE 258/260 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . WE ARE UNABLE TO CONFIRM THE COMPLAINT BECAUSE DEVICE WAS NOT RETURNED AND NO FURTHER INFORMATION FROM CUSTOMER HAS BEEN RECEIVED, THIS MATTER HAS TO BE CLOSED OUT WITH UNDETERMINED ROOT CAUSE.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00019 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON 03/01/2017 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER SOUGHT MEDICAL ATTENTION ON (B)(6) 2017 AT 10:30AM AFTER RECEIVING A BLOOD GLUCOSE RESULT OF 122 MG/DL ACCOMPANIED WITH FEELING DIZZY AND PASSING OUT. THE END USER'S WIFE QUESTIONED THE ACCURACY OF THE PRODIGY DIABETES GLUCOSE METER. THE PARAMEDICS WERE CALLED AND PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND RECEIVED A RESULT OF 27MG/DL. THE PARAMEDICS ADMINISTERED AN IV OF GLUCOSE FLUIDS TO STABILIZE HIS BLOOD GLUCOSE LEVEL. THE END USER WAS TRANSPORTED TO THE ER AND UPON ARRIVAL, HIS BLOOD GLUCOSE WAS 92 MG/DL. ADDITIONAL, IV GLUCOSE FLUIDS WERE GIVEN WHILE IN THE ER. NO ADDITIONAL TREATMENTS WERE ADMINISTERED. UPON DISCHARGE, THE END USER'S BLOOD GLUCOSE WAS 220 MG/DL AND HE WAS INSTRUCTED TO FOLLOW-UP WITH HIS PCP. NO ADDITIONAL INFORMATION WAS PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136024 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 72500 - D6160617-1

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention AMLODIPINE 10 MG ONCE DAILY| ASPIRIN 81 MG ONCE DAILY| BETAMETHAZONE 0.1% TWICE DAILY| CALCIUM CARBONATE 500MG 2 TABLETS TWICE A DAY| COLACE 100 MG 1 CAP 2 TIMES DAILY| CORTISPORIN 3.5-100-1 3 DROPS 4 TIMES DAILY| GABAPENTIN 100MG 1 CAPSULE PER DAY| GLIPIZIDE 10 MG 1 TABLET EVERY DAY| ISOSORBIDE MONONITRATE 60 MG ONCE EVERY DAY| LACTULOSE 10 MG ONE TABLESPOON PER DAY AS NEEDED| LANTUS SOLOSTAR 18 UNITS EVERY MORNING| LEVOTHYROXINE 75 MCG 1 TABLET A DAY| LISINOPRIL 5 MG ONCE A DAY| LOVASTATIN 20 MG ONCE A DAY| MECLIZINE 25 MG HALF A TABLET TO 1 TABLET EVERY 6H| NOVOLOG FLEXPEN 5-10 UNITS 3 TIMES A DAY WITH MEAL| TRIAMCINOLONE 0.1% TWICE DAILY| VITAMIN D 1000 UNITS ONCE DAILY