BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8810523 · Received July 22, 2019

    Report

    Report Number
    3005862821-2019-00030
    Event Type
    Injury
    Date Received
    July 22, 2019
    Date of Event
    May 12, 2019
    Report Date
    June 19, 2019
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384840518858
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. 1. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 17.1A. THE CRITERIA IS <55A. PASS. 2. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. 3. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER:D170517-1 , ONLY 5 PCS ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE HI/HI MG/DL, FOR LEVEL HIGH WERE HI/HI MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE OUT OF THE ACCEPTANCE RANGE. DESICCANT INSIDE THE STRIP BOTTLE HAD COLOR CHANGED. 4. WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (STRIP LOT NUMBER:D170517-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 66/70 MG/DL; FOR LEVEL HIGH WERE 246/242 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . STRIPS GET DAMP AND EXPIRED. PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS. USER STORAGE OR OPERATION ISSUE.

    Description of Event or Problem · 0

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2019-00030 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON (B)(6) 2019 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    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)(6) ON 07/19/2013. THE STRIP LOT # D170517-1 WAS MANUFACTURED ON 05/17/2017 AND EXPIRED ON 05/17/2019. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS. USER STORAGE OR OPERATION ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AT THE END-USERS HOME. THE END-USER STATED THAT SHE TOOK A BLOOD GLUCOSE TEST AROUND 7:00PM AND RECEIVED A RESULT IN THE 500 MG/DL. A NORMAL RESULT FOR THE END-USER FOR THAT TIME OF DAY IS 115MG/DL. SHE WAS UNSURE OF THE EXACT NUMBER. SHE THEN TOOK HER INSULIN BASED ON HER RESULT. SHORTLY THEREAFTER SHE STARTED TO FEEL ILL AND HER DAUGHTER TOOK HER TO THE ER. UPON ARRIVAL HER BLOOD GLUCOSE WAS 30MG/DL. THE END-USER WAS GIVEN AND IV WITH GLUCOSE AND WAS RELEASED 3-4 HOURS LATER WITHOUT BEING ADMITTED. SHE WAS NOT TREATED FOR ANYTHING ELSE AND WAS TOLD TO FOLLOW UP WITH HER PRIMARY CARE DOCTOR. SHE WAS TREATED AT (B)(6) MEDICAL CENTER LOCATED AT (B)(6). THE END-USER TAKES LANTUS- 65UNITS A DAY METFORMIN - 850MG/DL A DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604846 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D170517-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L ALLOPURINOL| ASPIRIN| FOLICIDE| LANTUS| LISINOPRIL| MAGNESIUM OXIDE| METFORMIN| PROZAC| SIMVASTATIN| ALLOPURINOL| ASPIRIN| FOLICIDE| LANTUS| LISINOPRIL| MAGNESIUM OXIDE| METFORMIN| PROZAC| SIMVASTATIN