BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6816080 · Received August 24, 2017

    Report

    Report Number
    3005862821-2017-00077
    Event Type
    Injury
    Date Received
    August 24, 2017
    Date of Event
    July 6, 2017
    Report Date
    July 7, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND FOUND THE METER SHOWS "E-T" ERROR CODE WHILE INSERTING INTO STRIPS, METER WAS NOT ABLE TO DO THE BLOOD TESTING. THE METER HAD DEFECTED EEPROM, THE INVESTIGATION REPORT AND CAPA WERE SENT TO IMPORTER, CAPA#: CP-2016021. THE CORRECTION AND CORRECTIVE ACTION WE TOOK AGAINST THIS DEFECTION WAS TO REMOVE THE EEPROM FROM METER, AND WE HAVE IMPLEMENT THIS SINCE YEAR OF (B)(6) 2014. BECAUSE PATIENT DID NOT RETURN HIS STRIPS (STRIP LOT#D160331-1).WE REVIEWED THE MANUFACTURER RECORD OF THAT STRIP BATCH, THE STRIP LOT # D160331-1 WAS MANUFACTURED ON 03/31/2016 AND EXPIRED IN 03/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM THE SAME MANUFACTURING BATCH OF STRIPS. WE TESTED THE RETAIN STRIPS (LOT#D16033-11) WITH IN HOUSE METER. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 58/58 MG/DL; FOR LEVEL HIGH WERE 246/244 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. SO THERE IS NOT FINDINGS ON THE STRIP BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 BETWEEN 5:00 - 6:00 PM. THE END USER STATED THAT HE PERFORMED A BLOOD GLUCOSE TEST WITH HIS PRODIGY DIABETES METER AT 4:00PM WITH A RESULT OF 561 MG/DL HE FELT FINE AND DID NOT HAVE ANY SIGNIFICANT SYMPTOMS. LATER HIS NEIGHBOR FOUND HIM PASSED OUT ON HIS COUCH AND THE PARAMEDICS WERE CALLED. THE END USER COULD NOT RECALL IF THE PARAMEDICS PERFORMED ANY BLOOD GLUCOSE TEST OR ADMINISTERED ANY MEDICATION. HE WAS TRANSPORTED TO THE ER AND UPON ARRIVAL HIS BLOOD GLUCOSE WAS 20 MG/DL. ONCE THE END USER WOKE UP HE WAS GIVEN A MEAL TO EAT AND HE WAS NOT COGNIZANT IF ANY TREATMENTS WERE RENDERED. AFTER SEVERAL HOURS AT THE ER THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 118 MG/DL. THE END WAS DIAGNOSED WITH LOW POTASSIUM AND BLOOD GLUCOSE. HE WAS ALSO INSTRUCTED TO FOLLOW-UP WITH HIS PCP. NO ADDITIONAL DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597567 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51900 52800-D160331-1

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention LANTUS 52 UNITS A DAY| NOVOLOG 12 UNITS A DAY| LANTUS 52 UNITS A DAY| NOVOLOG 12 UNITS A DAY