BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 11017708 · Received December 16, 2020

    Report

    Report Number
    3005862821-2020-00064
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    November 15, 2020
    Report Date
    December 3, 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

    1. NO NON-CONFORMITY WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED METER (SERIAL#: 51850-4070629) AND STRIPS (LOT#: D171031-1).2. 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 (3.1 UA) MET ACCEPTANCE CRITERIA (< 55 UA).3. STRIPS WERE MANUFACTURED ON 10/31/2017 AND WERE EXPIRED IN 10/2019. BECAUSE THE SUSPECTED STRIPS WERE EXPIRED AND OUT OF SPECIFICATIONS, THE SUSPECTED METER WAS TESTED BY USING ANY RETAINED STRIPS (LOT#: D190819-1) AND CONTROL SOLUTIONS (LEVEL LOW: BATCH# 9AH1A99, EXP. BY FEB., 2022; LEVEL HIGH: BATCH# 9AH3A16, EXP. BY JAN., 2022), AND RESULTS (LEVEL LOW: 46/40; LEVEL HIGH: 289/274) MET THE ACCEPTANCE CRITERIA(LEVEL LOW: 35~85; LEVEL HIGH: 220~330).4. EXPIRED STRIPS MAY CAUSE INACCURATE BLOOD GLUCOSE READINGS. WARNING INFORMATION REGARDING NOT TO USE EXPIRED STRIPS WAS DISCLOSED IN USER'S MANUAL AND STRIP LABELING TO AVOID THIS PROBLEM. FURTHERMORE, THE EXPIRATION DATE WAS SHOWN CLEARLY ON THE STRIP LABEL, STRIP BOX AND KIT BOX. THEREFORE, THE ROOT CAUSE OF THE COMPLAINT RESULTED FROM USER'S IMPROPER OPERATION.

    Description of Event or Problem · 1

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON 11-15-2020 AROUND 3:00AM AT HOME.END-USER STATED THAT SHE TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A RESULT OF 599MG/DL. A NORMAL RESULTAROUND THAT TIME OF DAY IS USUALLY AROUND 103MG/DL. END-USER STATED THAT SHE TOOK INSULIN (DID NOT DISCLOSE THE DOSAGE). SHESTATED THAT SHE THEN TESTED HER BLOOD GLUCOSE 3 MORE TIMES WITH HER PRODIGY METER AND RECEIVED RESULTS OF 599, HI, &599MG/DL.END-USER STATED THAT SHE IS PRESCRIBED 20MG OF HER INSULIN 3 TIMES A DAY. END-USER STATED THAT SHE WAS FEELING DROWSY. END-USERSTATED THAT SHE CALLED PARAMEDICS APPROXIMATELY 30-45 MINUTES AFTER TESTING WITH THE PRODIGY METER. SHE STATED THAT DID NOTCONSUME ANY FOOD DRINK OR MEDICATION WHILE WAITING FOR THE PARAMEDICS. PARAMEDICS ARRIVED WITHIN 10-15 MINUTES AND TESTED THEEND-USER'S BLOOD WITH THEIR METER AND RECEIVED A RESULT OF 40MG/DL. THE PARAMEDICS DID NOT TRANSPORT THE END-USER TO THE HOSPITAL.PARAMEDICS CHECKED HER VITALS AND ADVISED HER TO EAT. END-USER STATED THAT SHE ATE SPAGHETTI AND DRANK SWEET TEA. PARAMEDICSCHECKED THE END-USERS BLOOD GLUCOSE PRIOR TO LEAVING WITH THEIR METER AND RECEIVED A RESULT OF 120MG/DL. PARAMEDICS ADVISEDTHAT THE END-USER STAY AWAKE AND FOR HER HUSBAND TO MONITOR HER. END-USER WAS EDUCATED THAT HER TEST STRIPS ARE EXPIRED AND TONEVER USE EXPIRED PRODUCTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481836 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D171031-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other