BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 11270632 · Received February 2, 2021

    Report

    Report Number
    3005862821-2021-00005
    Event Type
    Injury
    Date Received
    February 2, 2021
    Date of Event
    December 29, 2020
    Report Date
    January 22, 2021
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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#: D190918-2). 2. RETURN AND RETAINED STRIPS (LOT#: D190918-2) WERE RE-TESTED BY USING RETURN (SERIAL#: (B)(4)) AND RETAINED (SERIAL#: (B)(4)) METERS WITH CONTROL SOLUTIONS (LEVEL LOW: BATCH# 9AH1A99, EXP. BY FEB., 2022; LEVEL HIGH: BATCH# 9AH3A16, EXP. BY JAN., 2022), RESPECTIVELY, AND RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA(LEVEL LOW: 35~85 ; LEVEL HIGH: 220~330). 2.1 RETURN METER W/ RETURN STRIPS: 63/60 (LEVEL LOW) AND 292/285 (LEVEL HIGH) 2.2 RETURN METER W/ RETAINED STRIPS: 72/73 (LEVEL LOW) AND 307/285 (LEVEL HIGH) 2.3 RETAINED METER W/ RETURN STRIPS: 56/60 (LEVEL LOW) AND 286/287 (LEVEL HIGH) 2.4 RETAINED METER W/ RETAINED STRIPS: 66/73 (LEVEL LOW) AND 289/272 (LEVEL HIGH) . 3. 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 (17.0 UA) MET ACCEPTANCE CRITERIA (< 55 UA). 4. AS ABOVE, NO NON-CONFORMANCE AND MALFUNCTION OF THE SUSPECTED DEVICE WERE FOUND. THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE VERIFIED WITHOUT MORE USERS' INFORMATION. THEREFORE, THE COMPLAINT HAD TO BE CLOSED OUT IF NO FURTHER ACTION FROM THE USER.

    Description of Event or Problem · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 8:00PM AT HOME. CALLER STATED THAT THE END-USER WAS UNRESPONSIVE, SO SHE TESTED HIS BLOOD GLUCOSE WITH HIS PRODIGY METER AND RECEIVED A RESULT OF 54MG/DL. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 180MG/DL. CALLER STATED THAT THE PARAMEDICS WERE CALLED IMMEDIATELY. CALLER STATED THAT NO FOOD DRINK OR MEDICATIONS WERE CONSUMED WHILE WAITING FOR THE PARAMEDICS. PARAMEDICS ARRIVED WITHIN 5 MINUTES AND TESTED THE END-USER BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 28MG/DL. CALLER STATED THAT THE END-USER WAS GIVEN SUGAR BY THE PARAMEDICS TO RAISE HIS BLOOD SUGAR. PARAMEDICS TRANSPORTED THE END-USER TO (B)(6) HOSPITAL LOCATED AT (B)(6). UPON ARRIVING AT THE HOSPITAL, THE END-USER HAD A BLOOD GLUCOSE OF 21MG/DL. CALLER STATED THE END-USER WAS PUT ON AN IV. CALLER STATED THAT THE END-USER WAS IN THE HOSPITAL FROM 12/29/2020 - 1/03/2021. WHEN THE END-USER WAS DISCHARGED HIS BLOOD GLUCOSE WAS 188MG/DL, AND HE WAS TOLD TO NOT TAKE ANY MORE INSULIN. CALLER DECLINED TO GIVE ALL MEDICATION PRESCRIBED TO THE END-USER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161079 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190918-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization