BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7085896 · Received December 6, 2017

    Report

    Report Number
    3005862821-2017-00132
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    August 5, 2017
    Report Date
    November 8, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841519007
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 12.0A. THE CRITERIA IS <55A. 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 60/55 MG/DL, FOR LEVEL HIGH WERE 222/229 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. BECAUSE PATIENT DID NOT RETURN HIS STRIPS, SO WE TESTED THE RETAIN STRIPS FROM OUR WAREHOUSE (SAME AS PATIENT'S STRIP LOT NUMBER: D161028-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 62/62 MG/DL; FOR LEVEL HIGH WERE 223/229 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 PDC ON 08/25/2016. THE STRIP LOT # D161028-2 WAS MANUFACTURED ON 10/28/2016 AND EXPIRED IN 10/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . OKB TESTED THE RETAIN STRIPS OF SAME BATCH FROM OUR WAREHOUSE WITH STANDARD METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 69/64 MG/DL; FOR LEVEL HIGH WERE 236/231 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. ACCORDING TO PATIENT, THE STRIPS WERE OPENED OVER 90 DAYS, WHICH EXCEEDS TO OUR USAGE REQUIREMENT TO BE USED IN 90 DAYS AFTER FIRST OPENING. PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READING.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00132 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON DEC. 20, 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 7:00 PM AFTER THE END USER ALLEGED THAT HIS PRODIGY DIABETES METER WAS READING HIGHER THAN NORMAL. THE END USER WAS NOT HAVING ANY SIGNIFICANT SYMPTOMS. THE CALLER STATED THAT THE END USER PERFORMED A BLOOD GLUCOSE TEST AND HE COULD NOT RECALL THE ACTUAL READING BUT BELIEVES IT WAS BETWEEN 159 - 200 MG/DL. THE END USER WANTED TO TAKE A DOSE OF INSULIN BASED UPON THE READING HE RECEIVED. HIS FAMILY FELT THAT HE DID NOT NEED THE INSULIN, SO THE END USER PROCEEDED TO CALL THE PARAMEDICS TO CLARIFY WHETHER HE NEEDED TO TAKE THE MEDICATION. UPON ARRIVAL, THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND HIS READING WAS 99 MG/DL. IT WAS DETERMINED THAT NO INSULIN WAS NEEDED DUE TO THE FACT THAT HIS BLOOD GLUCOSE WAS WITHIN NORMAL RANGE. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868930 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51900 52800 - D161028-2 00384841519007

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention AMITRIPTYLINE| ASPIRIN| BENZONATATE| BENZTROPINE| CLONAZEPAM| LEVEMIR| LEVETIRACETAM| LISINOPRIL| OLANZAPINE| OXCARBAZEPINE| OXYCODONE| PANTOPRAZOLE| PRAVASTATIN| RANITIDINE| TAMSULOSIN| TOPIRAMATE| VALPROIC ACID