BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7012485 · Received November 9, 2017

    Report

    Report Number
    3005862821-2017-00119
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 8, 2017
    Report Date
    October 8, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 RETURNED STRIPS (STRIP LOT NUMBER: D160816-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/56 MG/DL, FOR LEVEL HIGH WERE 251/250 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 FROM OUR WAREHOUSE (SAME LOT AS PATIENT'S STRIP : D160816-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 65/63 MG/DL; FOR LEVEL HIGH WERE 238/241 MG/DL. THE 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. 1. 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 PDC ON JULY 19, 2013. 2. THE STRIP LOT # D160816-1 WAS MANUFACTURED ON 08/16/2016 AND EXPIRED IN AUGUST 16, 2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . 3. OKB TESTED THE RETAIN STRIPS OF SAME BATCH FROM OUR WAREHOUSE. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 66/66 MG/DL; FOR LEVEL HIGH WERE 249/243 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 SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON (B)(6) 2017 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 1:00 AM AFTER THE END USER RECEIVED FALSE BLOOD GLUCOSE RESULTS FROM HIS PRODIGY DIABETES METER. THE END USER EXPERIENCED DIZZINESS, CONFUSION AND SHAKING ACCOMPANIED WTH A BLOOD GLUCOSE READING OF 103 MG/DL. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 40 MG/DL. THE END USER WAS GIVEN SUGAR WATER TO ASSIST IN STABILIZING HIS BLOOD GLUCOSE AND TRANSPORTED TO THE ER. ONCE HE ARRIVED TO THE ER HIS BLOOD GLUCOSE READING WAS 112 MG/DL. THE REPORTER COULD NOT RECALL AS TO WHAT PARTICULAR TREATMENT WAS GIVEN OR IF ADDITIONAL TEST WERE PERFORMED. AFTER 3 HOURS AT THE ER THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 110 MG/DL AND WAS INSTRUCTED TO FOLLOW-UP WITH HIS PCP. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793440 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D160816-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention AMLODIPINE BESYLATE 5 MG| ATORVASTATIN 40 MG| CLOPIDOGREL 75 MG| FISH OIL 1000| FUROSMIDE 20 MG| GABAPENTIN 300 MG| GLIPIZIDE 5 MG| LIPITOR| METFORMIN 500 MG| METOPROLOL 50 MG| NAMZARIC 28 MG / 10 MG| NEXIUM 40 MG| NIACIN 500 MG| PIOGLITAZONE 30 MG| POTASSUIM| QUINAPRI 20 MG| SULFAMETHOXAZOLE TMP DS TABS| TAMSULOSIN 0.4 MG| VITAMIN D