BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10827578 · Received November 12, 2020

    Report

    Report Number
    3005862821-2020-00059
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    October 6, 2020
    Report Date
    October 13, 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
    MI, 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#: D191114-1). THE METER WAS SHIPPED TO (B)(6) ON (B)(6) 2017. STRIPS WERE MANUFACTURED ON 11/14/2019 AND WILL EXPIRE IN 11/2021. 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#: D191114-1) FROM OKB'S WAREHOUSE WERE STILL FUNCTIONAL. RETAINED STRIPS WERE USED TO RE-TEST WITH IN-HOUSE METER (SERIAL#: (B)(4)) AND CONTROL SOLUTION (LEVEL LOW: BATCH#: 9AH1A99, EXP. BY FEB. 2022; LEVEL HIGH: BATCH#: 9AH3A16, EXP. BY JAN. 2022), AND RESULTS (LEVEL LOW: 58/65; LEVEL HIGH: 280/272) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 30~80; LEVEL HIGH: 210~320). 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 11:30 PM AT HOME. END-USER STATED THAT SHE TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED ARE RESULT OF 455 MG/DL, A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 135 MG/DL. THE END-USER STATED THAT SHE DID NOT TEST AGAIN BUT THAT HER DAUGHTER THEN TOOK HER TO THE HOSPITAL, AFTER SHE COMPLAINED OF A HEADACHE AND FEET PAIN (?). SHE DID NOT HAVE ANY FOOD DRINK OR MEDICATIONS PRIOR TO GOING TO THE HOSPITAL. SHE STATED THAT WHEN SHE ARRIVED AT (B)(6) MEDICAL CENTER - EMERGENCY ROOM LOCATED AT (B)(6) HER BLOOD GLUCOSE WAS 131 MG/DL. NO TREATMENT WAS RECEIVED SHE STATED THAT SHE WAS AT THE HOSPITAL FOR 4 HOURS. THE END-USER STATED THAT SHE WAS TOLD TO FOLLOW UP WITH HER DOCTOR, HER BLOOD GLUCOSE WAS NOT CHECKED BEFORE SHE WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295434 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D191114-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR