BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6992582 · Received November 1, 2017

    Report

    Report Number
    3005862821-2017-00113
    Event Type
    Injury
    Date Received
    November 1, 2017
    Date of Event
    August 29, 2017
    Report Date
    September 28, 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

    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 02/23/2017. 2. THE STRIP LOT # D161229-1 WAS MANUFACTURED ON 12/29/2016 AND EXPIRED IN 12/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . 3. BECAUSE PATIENT DID NOT RETURN HIS STRIPS, WE TESTED THE RETAIN STRIPS OF SAME BATCH FROM OUR WAREHOUSE HOUSE. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 54/59 MG/DL; FOR LEVEL HIGH WERE 232/226 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 40~90 MG/DL; LEVEL HIGH 210~320 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

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 (TIME UNKNOWN) AFTER THE END USER RECEIVED LOW BLOOD GLUCOSE READINGS FROM HIS PRODIGY DIABETES METER. THE END USER PERFORMED A BLOOD GLUCOSE TEST AND RECEIVED A LO READING. HE PROCEEDED TO PERFORM AN ADDITIONAL TEST WITH A RESULT OF 24 MG/DL. THERE WERE NO SIGNIFICANT SYMPTOMS BUT OUT OF CONCERN FOR THE LOW READINGS THE PARAMEDICS WERE CALLED. UPON ARRIVAL THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 142 MG/DL. NO TREATMENT WAS ADMINISTERED AND IT WAS NOT NECESSARY FOR THE END USER TO BE TRANSPORTED TO THE ER DUE TO THE FACT THAT HIS BLOOD GLUCOSE READING 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
    772033 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D161229-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention ALBUTEROL INHALER 2X DAILY| ASPIRIN 81 MG 1 TABLET DAILY| LEVEMIR 10 UNITS ONCE DAILY| MAGNESIUM OXIDE 400 MG TABLET 2X DAILY| POTASSIUM CHLORIDE 10 MG 1 DAILY