BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7551937 · Received May 30, 2018

    Report

    Report Number
    3005862821-2018-00031
    Event Type
    Injury
    Date Received
    May 30, 2018
    Date of Event
    March 31, 2018
    Report Date
    May 2, 2018
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384840518858
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED METER WAS EVALUATED BY OK BIOTECH AND CALCULATED THE STRIP CONNECTOR ON THE METER WAS DIRTY WHICH CONTRIBUTED DISABLE ON THE METER. USER MIGHT APPLY BLOOD OR CONTROL SOLUTION INAPPROPRIATELY OR FAILURE TO APPROPRIATELY MAINTAIN THE DEVICES. FIRST WHEN WE RECEIVED THE METER, WE INSERTED TEST STRIP INTO METER, THE METER WAS NOT WORKABLE. WE DISASSEMBLED THE METER AND FOUND THE DUST/DIRT DISTRIBUTED ON THE ELECTRONIC BOARD AND STRIP CONNECTOR. AFTER WE BLOWING THE DUST OFF WITH THE AIR GUN, METER WAS RESPONSABLE WHEN WE INSERT STRIPS. THEN, WE CHECK THE SUSPECTED METER THROUGH OUR STANDARD PROCEDURES AND CALCULATED THAT THE METER WAS OPERATED WITHIN SPECIFICATIONS AFTER WE CLEANED UP. FOLLOWINGS ARE THE SUMMARY OF OUR ROUTINE TEST AFTER METER CLEANED UP: THE STANDBY CURRENT OF THE METER WAS 1.3¿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: D170427-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 58/64 MG/DL, FOR LEVEL HIGH WERE 261/266 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS . WE TESTED THE RETAIN STRIPS (STRIP LOT NUMBER: D170427-1) WITH RETURNED METER. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/63 MG/DL; FOR LEVEL HIGH WERE 256/260 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 35~85 MG/DL; LEVEL HIGH 210~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 1

    END-USER ALLEGED THAT MEDICAL ATTENTION WAS NEEDED ON (B)(6) 2018 AT 1000 DUE TO "HAVING THE SHAKES AND BEING CONFUSED". END USER ATTEMPTED TO USE THE PRODIGY METER BUT THE METER DID NOT RESPOND TO THE TEST STRIP INSERTED AT THE TIME OF THE EVENT. PARAMEDICS WERE IMMEDIATELY CALLED. WHILE WAITING FOR THE PARAMEDICS TO ARRIVE THE END-USER CHEWED 2 RELION GLUCOSE TABS AND DRANK ORANGE JUICE. WHEN THE PARAMEDICS ARRIVED THE END-USERS BLOOD GLUCOSE WAS 42 MG/DL, END-USER RECEIVED A TUBE OF GLUCOSE AND WAS TRANSPORTED TO THE HOSPITAL. UPON ARRIVAL AT THE HOSPITAL THE END-USER'S BLOOD GLUCOSE WAS AROUND 100 MG/DL, END-USER STATED SHE DOES NOT RECALL THE EXACT NUMBER. END-USER WAS GIVEN A SANDWICH TO EAT AND TWO GLASSES OF ORANGE JUICE. END-USER WAS IN THE HOSPITAL FOR ABOUT AN HOUR AND WAS DISCHARGED WITH A BLOOD GLUCOSE OF 252 MG/DL AND WAS GIVEN INSTRUCTIONS TO FOLLOW UP WITH PCP. NO ADDITIONAL INFORMATION WAS RECEIVED IN REGARDS TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396880 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. D170427-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention ASPIRIN| CENTRUM| CLARITIN| GABAPENTIN| LANTUS| LASIX| LATUDA| LEXAPRO| LIPITOR| METOPROLOL| NOVOLOG| TOPAMAX| TRADJENTA| TRAZODONE| WELLBUTRIN| ZANTAC