BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10107510 · Received June 1, 2020

    Report

    Report Number
    3005862821-2020-00028
    Event Type
    Injury
    Date Received
    June 1, 2020
    Date of Event
    April 12, 2020
    Report Date
    May 5, 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-CONFORMANCE WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED DEVICE (METER SERIAL#: (B)(4). METER SETTING AND ALL FUNCTIONS OF THE SUSPECTED DEVICE WERE RE-TESTED, AND ALL OF THEM WERE OPERATED PROPERLY. STANDBY CURRENT OF THE DEVICE WAS RE-CHECKED AND THE CURRENT (1.2 UA) MET ACCEPTANCE CRITERIA (< 55 UA). BECAUSE NO INFORMATION OF SUSPECTED STRIPS WERE PROVIDED, THE SUSPECTED METER WAS TESTED BY USING ANY RETAINED STRIPS (LOT#: D190909-1) AND CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A94, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A14, EXP. BY SEPT., 2020), AND RESULTS (LEVEL LOW: 54/47; LEVEL HIGH: 256/266) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 30~80; LEVEL HIGH: 200~310). THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE VERIFIED WITHOUT THE SUSPECTED STRIPS 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 1:30AM AT HOME. CALLER STATED THAT THE END-USER WAS FOUND UNRESPONSIVE AND WHEN HER BLOOD GLUCOSE WAS TESTED WITH HER PRODIGY METER SHE RECEIVED A RESULT OF 271MG/DL. CALLER DOES NOT KNOW WHAT HER BLOOD GLUCOSE WOULD BE AT THAT TIME OF DAY DUE TO THE END-USER NOT NORMALLY TESTING AT 1:30AM. CALLER STATED THAT THE PARAMEDICS WERE CALLED ABOUT 10 MINUTES AFTER TESTING WITH THE PRODIGY METER. PARAMEDICS ARRIVED IN ABOUT 10MINUTES AND TESTED THE END-USER WITH THEIR METER AND RECEIVED A RESULT OF 77MG/DL CALLER STATED THE END-USER DID NOT GET ANY TREATMENT FROM THE PARAMEDICS. THE END END-USER WAS TRANSPORTED TO THE HOSPITAL BY THE PARAMEDICS. THE CALLER DID NOT PROVIDE ANY ADDITIONAL INFORMATION. ATTEMPTS WERE MADE TO GET ADDITIONAL INFORMATION WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571197 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization