BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10424157 · Received August 19, 2020

    Report

    Report Number
    3005862821-2020-00047
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    June 25, 2020
    Report Date
    August 12, 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#: D181205-1). THE METER WAS SHIPPED TO PDC ON 04/16/2019. STRIPS WERE MANUFACTURED ON 12/05/2018 AND WILL EXPIRE IN 12/2020. 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#: D181205-1) 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: 55/56; LEVEL HIGH: 233/227) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 30~80 ; LEVEL HIGH: 200~310). 3. BASED ON THE PDC'S REPORT, PATIENT'S STRIPS WERE OPEN FOR MORE THAN 90 DAYS, WHICH IS EXPIRED OF USAGE AND MIGHT CAUSED TO HIGHER TEST RESULTS. USER STORAGE OR OPERATION ISSUE.

    Description of Event or Problem · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 7:00PM AT HOME. CALLER STATED THAT THE END-USERS BLOOD GLUCOSE WAS TESTED, AND HE RECEIVED A RESULT OF 101MG/DL. THE END-USER TESTS 3-4 TIMES A DAY AND A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 100-150MG/DL. CALLER STATED THAT PARAMEDICS WERE CALLED IMMEDIATELY AFTER TESTING DUE TO THE END-USER BEING SHAKY, SWEATY AND FOR BECOMING SLIGHTLY UNRESPONSIVE. NO FOOD DRINK OR MEDICATION WAS CONSUMED WHILE WAITING FOR THE PARAMEDICS. PARAMEDICS ARRIVED AROUND 5 MINUTES LATER AND TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND THEY RECEIVED A RESULT OF 23MG/DL. PARAMEDICS GAVE THE END-USER A GLUCOSE SOLUTION A POPSICLE FRUIT AND A PEANUT BUTTER AND JELLY SANDWICH. THE PARAMEDICS DID NOT TRANSPORT THE END-USER TO THE HOSPITAL. THE END-USER TAKES 20 UNITS OF BASAGLAR INSULIN TOTAL ( MUST TAKE TWICE A DAY ) 10 UNITS IN THE AM 10 UNITS IN THE EVENING. PARAMEDICS DID NOT CHECK THE END-USERS BLOOD GLUCOSE WHEN THEY LEFT. CALLER AND THE END-USER WERE INFORMED THAT THE TEST STRIPS WERE NO GOOD DUE TO BEING OPEN FOR MORE THAN 90 DAYS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890967 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D181205-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization