BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6224329 · Received January 4, 2017

    Report

    Report Number
    3005862821-2017-00001
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    November 29, 2016
    Report Date
    November 29, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 06/07/2016. THE STRIP LOT #D160127-2 WAS MANUFACTURED ON 01/27/2016 AND EXPIRED IN 01/2018. OK BIOTECH RECEIVED 1 COMPLAINT FROM SAME MANUFACTURING BATCH OF STRIPS ON 12/05/2016 FOR ABSORBANCE SPEED SLOW AFTER APPLIED BLOOD INTO STRIP. BUT THE COMPLAINT OF THIS INITIAL REPORT WAS FOR HIGHER READING COMPLAINT, WHICH WAS NOT RELATED TO ABSORBANCE PROBLEM. OKB TESTED THE RETAIN STRIPS. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 52/49 MG/DL; FOR LEVEL HIGH WERE 235/240 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. 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.

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF THE RETURNED METER, THE RESULT OF TEST 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:D160127-2, ONLY 3 STRIPS IN THE BOTTLE RETURNED FROM PATIENT). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 45 MG/DL; FOR LEVEL HIGH WERE 256 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. WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME BATCH, STRIP LOT NUMBER:D160127-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 52/49 MG/DL, FOR LEVEL HIGH WERE 235/240 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. SO THERE IS NO QUALITY DIFFERENCE ON THE RETURNED STRIPS AND OUR RETAIN STRIPS FROM WAREHOUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2016 AT 2:15 PM AFTER THE END USER WAS ASLEEP, FELT COLD TO THE TOUCH AND WOULD NOT WAKE UP. HER SON CHECKED HER BLOOD GLUCOSE WITH THE PRODIGY DIABETES METER AND THE RESULT WAS 130 MG/DL. FEELING UNCOMFORTABLE WITH THE BLOOD GLUCOSE RESULT ACCOMPANIED WITH THE END USER'S SYMPTOMS HER SON CALLED THE PARAMEDICS. THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND RECEIVED A RESULT OF 40 MG/DL. SHE RECEIVED AN IV OF FLUID TO RAISE HER BLOOD GLUCOSE. THE END USER COULD NOT RECALL WHAT WAS ADMINISTERED INTRAVENOUSLY. SHE WAS THEN TRANSPORTED TO THE E.R. AND WAS ADMITTED TO THE HOSPITAL FOR A LENGTH OF FOUR DAYS. SHE WAS GIVEN AN IV OF FLUID TO RAISE HER BLOOD GLUCOSE LEVEL. UPON DISCHARGE, HER BLOOD GLUCOSE WAS 161 MG/DL AND SHE WAS INSTRUCTED TO FOLLOW-UP WITH HER PCP. THE END USER'S PCP CHANGED HER LEVEMIR FROM 60 UNITS AT NIGHT TO 45 UNITS. NO FURTHER DETAILS WERE PROVIDED.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00001 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON 02/14//2017 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5833 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800-D160127-2

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R AMITRIPTYLINE AT NIGHT| AMLODIPINE/VALSARTAN| ASPIRIN 1 A DAY| CARVEDILOL| GABAPENTIN| LASIX| LEVEMIR 45 UNITS AT NIGHT| LOVASTATIN| METFORMIN HCL| NOVOLOG 3X A DAY| POTASSIUM CHLORIDE| TRADJENTA