BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9961289 · Received April 15, 2020

    Report

    Report Number
    3005862821-2020-00018
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    March 5, 2020
    Report Date
    March 17, 2020
    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

    NO NON-CONFORMITY WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D190509-1). THE METER WAS SHIPPED TO PDC ON 07/05/2013. STRIPS WERE MANUFACTURED ON 05/09/2019 AND WILL EXPIRE IN 05/2021. BECAUSE THE SUSPECTED BGMS WAS NOT RETURNED TO OKB, THE RETAINED METER (SERIAL#: (B)(4)) WAS USED TO RE-TEST, AND THE COMPLAINT SITUATIONS DID NOT OCCUR. BESIDES, DESICCANTS OF RETAINED STRIPS (LOT#: D190509-1) FROM OKB'S WAREHOUSE WERE STILL FUNCTIONAL (ORANGE COLOR). RETAINED STRIPS WERE USED TO RE-TEST WITH IN-HOUSE METER (SERIAL#: (B)(4)) AND CONTROL SOLUTION (LEVEL LOW: BATCH# 8AH1A94, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A14, EXP. BY SEPT., 2020), AND RESULTS (LEVEL LOW: 65/65; LEVEL HIGH: 238/243) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85; LEVEL HIGH: 220~330). THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE VERIFIED WITHOUT THE SUSPECTED BGMS AND MORE USERS' INFORMATION. THEREFORE, THE COMPLAINT HAD TO BE CLOSED OUT IF NO FURTHER ACTION OR INFORMATION FROM THE USER.

    Description of Event or Problem · 1

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 4:00PM AT HOME. END-USER STATED HE TESTED HI BLOOD GLUCOSE WITH HIS PRODIGY METER IN THE MORNING AND RECEIVED A HIGH READING OF 298MG/DL, WHICH PROMPTED HIM TO TAKE 3 UNITS OF INSULIN. CALLER THEN STATED HE TOOK 13 UNITS OF INSULIN IN THE AFTERNOON AND DROVE TO A STORE AND WAS FOUND UNCONSCIOUS IN THE PARKING LOT. A NORMAL RESULT FOR THE END-USER IN THE MORNING IS AROUND 110MG/DL. HE WAS GIVEN APPLE JUICE WHILE WAITING FOR THE EMS TO ARRIVE. WHEN THE EMS ARRIVED, THEY CHECKED HIS BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 24MG/DL. HE WAS THEN GIVEN GLUCOSE(DID NOT SPECIFY WHAT FORM) AND TRANSPORTED TO THE HOSPITAL. WHEN HE ARRIVED AT (B)(6) HOSPITAL LOCATED AT (B)(6), HIS BLOOD GLUCOSE WAS CHECKED AGAIN WITH THE HOSPITALS METER AND THEY GOT A RESULT 69MG/DL. HE WAS GIVEN 2 TURKEY SANDWICHES GRAHAM CRACKERS APPLE AND ORANGE JUICE TO RAISE HIS GLUCOSE LEVELS. HE STATED THAT HE WAS DISCHARGED AFTER 4 HOURS AND WAS TOLD NOT TO TAKE HIS EVENING MEDICATION DUE TO HIS BLOOD GLUCOSE BEING 268MG/DL WHEN HE WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426931 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190509-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization