BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9846391 · Received March 18, 2020

    Report

    Report Number
    3005862821-2020-00012
    Event Type
    Injury
    Date Received
    March 18, 2020
    Date of Event
    February 10, 2020
    Report Date
    February 19, 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#: D181011-3). THE METER WAS SHIPPED TO (B)(6) ON 10/24/2016. STRIPS WERE MANUFACTURED ON 10/11/2018 AND WILL EXPIRE IN 10/2020. 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#: D181011-3) 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# 8AH1A94, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A14, EXP. BY SEPT., 2020), AND RESULTS (LEVEL LOW: 66/70; LEVEL HIGH: 265/262) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85; LEVEL HIGH: 200~310). 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 1:00PM AT HOME. CALLER STATED THAT HE TESTED THE END-USERS BLOOD GLUCOSE AND RECEIVED A RESULT OF 300MG/DL. HER NORMAL RESULTS FOR THAT TIME OF DAY ARE AROUND 140MG/DL. BOUT 30 MINUTES AFTER TESTING THE END-USER APPEARED TO BE UNRESPONSIVE AND WOULD NOT RESPOND WHEN SPOKEN TO. CALLER THEN CALLED THE PARAMEDICS. WHILE WAITING FOR PARAMEDICS NO FOOD OR MEDICATION WERE TAKEN. PARAMEDICS ARRIVED WITHIN 3 MINUTES AND TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND GOT A RESULT OF 44MG/DL. THE END-USER WAS GIVEN AN IV WITH GLUCOSE SOLUTION. SHE WAS NOT TRANSPORTED TO THE HOSPITAL. PRIOR TO THE PARAMEDICS LEAVING HER BLOOD GLUCOSE WAS 168MG/DL. SHE WAS ADVISED TO FOLLOW UP WITH HER DOCTOR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311391 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D181011-3 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening