BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10050172 · Received May 12, 2020

    Report

    Report Number
    3005862821-2020-00025
    Event Type
    Injury
    Date Received
    May 12, 2020
    Date of Event
    April 9, 2020
    Report Date
    April 20, 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#: D190610-1). THE METER WAS SHIPPED TO PDC ON 09/04/2019. STRIPS WERE MANUFACTURED ON 06/10/2019 AND WILL EXPIRE IN 06/2021. BECAUSE THE SUSPECTED BGMS WAS NOT RETURNED TO OKB, THE RETAINED METER (SERIAL#: OK-A QC-01) WAS USED TO RE-TEST, AND THE COMPLAINT SITUATIONS DID NOT OCCUR. BESIDES, DESICCANTS OF RETAINED STRIPS (LOT#: D190610-1) 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: 52/53; LEVEL HIGH: 226/227) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 45~95; 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

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 3:45AM AT HOME. CALLER STATED THEY WOKE UP TO HEAR MOANING WENT TO GO CHECK IN ON THE END-USER TO FIND HER IN HER BED UNRESPONSIVE. CALLER STATED THAT SHE IMMEDIATELY TESTED THE END-USER'S BLOOD GLUCOSE AND RECEIVED A RESULT OF 77MG/DL. THE CALLER STATED THAT THE END USERS BLOOD GLUCOSE IS USUALLY AROUND 98-102MG/DL. CALLER THEN CALLED PARAMEDICS WHO ARRIVED WITHIN 7 MINUTES, PARAMEDICS TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 37MG/DL. PARAMEDICS STARTED A GLUCOSE SOLUTION IV AND GAVE THE END-USER GLUCOSE BY MOUTH. THE END-USER WAS NOT TRANSPORTED TO THE HOSPITAL BY THE PARAMEDICS. PRIOR TO THE PARAMEDICS LEAVING THE CALLER STATED THAT THE END-USERS BLOOD GLUCOSE WAS 240MG/DL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509614 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190610-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention