BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8427369 · Received March 17, 2019

    Report

    Report Number
    3005862821-2019-00017
    Event Type
    Injury
    Date Received
    March 17, 2019
    Date of Event
    February 13, 2019
    Report Date
    February 21, 2019
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384840518858
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 1.2UA. THE CRITERIA IS <55UA. 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: D180116-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 55/58 MG/DL, FOR LEVEL HIGH WERE 242/250 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

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AT 2PM DUE TO THE METER GIVING A HIGH RESULT OF 527MG/DL. ENDUSER TESTED WITH THE PRODIGY METER 5 MORE TIMES AND RECEIVED RESULTS HIGHER THAN NORMAL RESULTS. END-USER STATED SHE WAS FEELING DIZZY AND SWEATY AFTER GETTING THE HIGH RESULT. SHE STATED THAT A NORMAL READING FOR THIS TIME OF DAY IS 140MG/DL. END-USER STATED SHE TOOK METFORMIN AND ATE A LUNCH OF A WHOPPER FRENCH FRIES AND CANDY PRIOR TO TAKING HER BLOOD GLUCOSE. SHE THEN TESTED 5 MORE TIMES AND RECEIVED RESULTS OF 20, 231, 291, 327, 356MG/DL. SHE THEN HAD SOMEONE TAKE HER TO THE ER WHERE UPON ARRIVAL HER BLOOD GLUCOSE WAS 289MG/L. SHE DID NOT RECEIVE ANY TREATMENT TO RAISE OR LOWER HER BLOOD GLUCOSE. SHE WAS IN THE ER FOR APPROXIMATELY 2 HOURS AND WAS NOT ADMITTED. SHE WENT TO (B)(6) HOSPITAL LOCATED AT (B)(6). SHE STATED THAT HER BLOOD GLUCOSE WAS NOT CHECKED PRIOR TO HER LEAVING THE HOSPITAL. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220427 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D180116-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention ABILIFY| AMLODIPINE BESYLATE| ATENOLOL| BABY ASPIRIN| FENOFIBRATE| JANUVIA| LOSARTAN| LOVASTATIN| METFORMIN| NEXIUM| ROBAXIN| WELLBUTRIN| ZONTIVITY