BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 8251830 · Received January 16, 2019

    Report

    Report Number
    3005862821-2019-00002
    Event Type
    Injury
    Date Received
    January 16, 2019
    Date of Event
    November 25, 2018
    Report Date
    December 28, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. 1. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.5A. THE CRITERIA IS <55A. PASS. 2. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. 3. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND IN HOUSE STRIPS (STRIP LOT NUMBER:D180315-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/59 MG/DL, FOR LEVEL HIGH WERE 266/259 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. 4. PATIENT'S STRIP LOT#D131223-1 WAS MANUFACTURED ON DEC. 23, 2013 AND EXPIRED IN DEC. 2015, WHICH IS EXPIRED FOR MORE THAN 3 YEARS. PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS. USER ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2018 BETWEEN 3:00-3:30 PM AFTER THE END-USER RECEIVED 3 RESULTS OF HI FROM HIS PRODIGY DIABETES METER. THE END-USER STATED THAT DUE TO GETTING RESULTS OF HI, HE TOOK 8 UNITS OF HUMALOG WHICH CAUSED HIM TO PASS OUT. EMS WAS CALLED AND ARRIVED WITHIN 5 MINUTES. EMS STARTED AN IV AND TRANSPORTED THE END-USER TO THE ER. END-USER DOES NOT RECALL WHAT HIS BLOOD SUGAR WAS WHEN HE ARRIVED. END-USER STATED HE WAS GIVEN IV FLUIDS BUT CANNOT RECALL WHAT HE WAS GIVEN. HE WAS ALSO GIVEN MEDICINE TO LOWER HIS BLOOD PRESSURE DUE TO IT BEING TOO HIGH. END-USER WAS HOSPITALIZED FOR 2 DAYS. HIS BLOOD SUGAR WAS 177MG/DL UPON DISCHARGE AND HE WAS TOLD TO FOLLOW UP WITH HIS PRIMARY DR. END-USER WAS TREATED AT (B)(6) HOSPITAL LOCATED AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46597 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D131223-1 00384840518858

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization ALOGLIPTIN 25 MG 1 PILL IN THE MORNING| ATORVASTATIN 20 MG ONCE A DAY| LEVOTHYROXINE 75MG| LISINOPRIL 10 MG| VITAMIN D 100 UNITS