BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10498631 · Received September 7, 2020

    Report

    Report Number
    3005862821-2020-00049
    Event Type
    Injury
    Date Received
    September 7, 2020
    Date of Event
    August 10, 2020
    Report Date
    September 1, 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
    FL, 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#: D190710-1). THE METER WAS SHIPPED TO PDC ON 10/15/2019. STRIPS WERE MANUFACTURED ON 07/10/2019 AND WILL EXPIRE IN 07/2021. 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#: D190710-1) 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# 8AH1A95, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A15, EXP. BY DEC., 2020), AND RESULTS (LEVEL LOW: 55/60; LEVEL HIGH: 258/257) 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 10:00PM AT HOME. END-USER STATED THAT SHE RECEIVED A BLOOD GLUCOSE RESULT OF 5MG/DL AND SHE THEN PRESSED HER LIFE ALERT BUTTON. END-USER WAS EDUCATED THAT THE PRODIGY METER DOES NOT GIVE RESULTS LESS THAN 20MG/DL. END-USER STATED THAT A NORMAL BLOOD GLUCOSE RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 90-120MG/DL. SHE STATED THAT SHE WAS FEELING DIZZY AND FELT AS THOUGH SHE WAS BLACKING OUT. PARAMEDICS WERE CALLED APPROXIMATELY 25 MINUTES AFTER TESTING WITH HER PRODIGY METER. WHILE WAITING FOR PARAMEDICS TO ARRIVE SHE STATED SHE DRANK A SODA AND TOOK SOME GLUCOSE TABLETS. PARAMEDICS ARRIVED ABOUT 20 MINUTES LATER AND TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 90MG/DL. THEY ALSO PERFORMED A BLOOD GLUCOSE TEST WITH THE END-USERS PRODIGY METER AND RECEIVED A RESULT OF 100MG/DL. PARAMEDICS GAVE THE END-USER CRACKERS AND TRANSPORTED HER TO (B)(6) HOSPITAL LOCATED AT (B)(6). UPON ARRIVING AT THE HOSPITAL, THE END-USERS BLOOD GLUCOSE WAS 110MG/DL. SHE STATED THAT SHE WAS GIVEN A GLUCOSE IV AND A SANDWICH. THE END-USER STATED THAT SHE WAS AT THE HOSPITAL FOR 6 HOURS. UPON DISCHARGE THE END-USER STATED THAT HER BLOOD GLUCOSE WAS 110MG/DL, AND SHE WAS TOLD TO FOLLOW UP WITH HER PRIMARY CARE DOCTOR. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964158 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190710-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization