BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10050174 · Received May 12, 2020

    Report

    Report Number
    3005862821-2020-00026
    Event Type
    Injury
    Date Received
    May 12, 2020
    Date of Event
    March 1, 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-CONFORMANCE WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED DEVICE (METER SERIAL#: (B)(4) AND STRIP LOT#: D190201-2). RETURN AND RETAINED STRIPS (LOT#: D190201-2) WERE RE-TESTED BY USING RETURN (SERIAL#: (B)(4)) AND RETAINED (SERIAL#: (B)(4)) METERS WITH CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A94, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A14, EXP. BY SEPT., 2020), RESPECTIVELY, AND RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85; LEVEL HIGH: 200~310). RETURN METER W/ RETURN STRIPS: 66/65 (LEVEL LOW) AND 271/281 (LEVEL HIGH). RETURN METER W/ RETAINED STRIPS: 67/69 (LEVEL LOW) AND 277/271 (LEVEL HIGH). RETAINED METER W/ RETURN STRIPS: 66/72 (LEVEL LOW) AND 272/284 (LEVEL HIGH). RETAINED METER W/ RETAINED STRIPS: 60/59 (LEVEL LOW) AND 240/232 (LEVEL HIGH). 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 (1.6 UA) MET ACCEPTANCE CRITERIA (< 55 UA). AS ABOVE, NO NON-CONFORMANCE AND MALFUNCTION OF THE SUSPECTED DEVICE WERE FOUND. THE MATTER MIGHT RESULT FROM USER'S OPERATION OR PRESERVATION. THE ROOT CAUSE OF THE COMPLAINT IS UNABLE TO BE VERIFIED WITHOUT MORE USERS' INFORMATION.

    Description of Event or Problem · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) AROUND 10:00AM AT HOME. CALLER STATED SHE WENT TO CHECK ON HER FATHER IN THE MORNING AND HE WAS FOUND UNRESPONSIVE. THE END-USERS BLOOD GLUCOSE WAS TESTED, AND SHE RECEIVED A RESULT OF 244MG/DL., A NORMAL RESULT FOR THAT TIME OF DAY IS AROUND 110MG/DL SHE THEN CALLED THE PARAMEDICS, WHO ARRIVED WITHIN 5-10 MINUTES. PARAMEDICS TESTED THEN END-USER WITH THEIR METER AND RECEIVED A RESULT OF 44MG/DL. THE CALLER WAS UNSURE IF THE PARAMEDICS TESTED THE END-USER WITH THE PRODIGY METER OR WHAT TREATMENT HE RECEIVED FROM THEM. THE END-USER WAS TRANSPORTED TO (B)(6) BY PARAMEDICS. CALLER DID NOT RECALL WHAT THE END-USERS BLOOD GLUCOSE WAS WHEN HE ARRIVED AT THE HOSPITAL. THEN END-USER WAS ADMITTED TO THE HOSPITAL DUE TO HIS BLOOD GLUCOSE BEING LOW FOR 3 NIGHTS. CALLER DID NOT DISCLOSE WHAT TREATMENT HE RECEIVED OR WHAT TESTS WERE PERFORMED. THE CALLER STATED THAT THE END-USER'S INSULIN WAS LOWERED AND THAT HE IS NO LONGER TAKING INVOKAMET AFTER SEEKING MEDICAL ATTENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509615 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190201-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization