BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9881767 · Received March 25, 2020

    Report

    Report Number
    3005862821-2020-00013
    Event Type
    Injury
    Date Received
    March 25, 2020
    Date of Event
    February 17, 2020
    Report Date
    February 26, 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#: D190610-1). RETURN AND RETAINED STRIPS (LOT#: D190610-1) WERE RE-TESTED BY USING RETURN METER (SERIAL#: (B)(4)) AND RETAINED METER (SERIAL#: (B)(4)) 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: 45~95; LEVEL HIGH: 220~330). RETURN METER W/ RETURN STRIPS: 67/63 (LEVEL LOW) AND 294/289 (LEVEL HIGH). RETURN METER W/ RETAINED STRIPS: 61/63 (LEVEL LOW) AND 263/244 (LEVEL HIGH). RETAINED METER W/ RETURN STRIPS: 66/62 (LEVEL LOW) AND 278/283 (LEVEL HIGH). RETAINED METER W/ RETAINED STRIPS: 65/65 (LEVEL LOW) AND 238/243 (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 (3.3 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

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 2:00PM AT HOME. THE END-USER STATED THAT SHE TESTED HER BLOOD GLUCOSE AND SHE RECEIVED A RESULT OF 422MG/DL. A NORMAL RESULT FOR THAT TIME OF DAY IS AROUND 100-200MG/DL. SHE STATED THAT SHE DID NOT DO ANOTHER TEST WITH HER PRODIGY METER. SHE STATED THAT ABOUT 5 MINUTES AFTER TESTING WITH THE PRODIGY METER SHE WAS EXPERIENCING DIZZINESS, SHORTNESS OF BREATH, A HEADACHE, AND DRY MOUTH. SHE THEN CALLED PARAMEDICS WHO ARRIVED WITHIN 2 MINUTES. SHE SAID SHE DID NOT CONSUME ANY FOOD DRINK OR MEDICATIONS WHILE WAITING FOR THE PARAMEDICS. UPON ARRIVING THE PARAMEDICS TESTED HER BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 180MG/DL. THEY THEN TESTED HER WITH HER PRODIGY METER AND GOT A RESULT OF 386MG/DL. PARAMEDICS DID NOT GIVE THE END-USER ANY TREATMENT DUE TO HER BLOOD GLUCOSE BEING IN HER NORMAL RANGE. THE END-USER STATED THAT SHE PERFORMED A CONTROL SOLUTION TEST AFTER THE PARAMEDICS LEFT AND GOT A RESULT OF 55MG/DL WHICH WAS IN RANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343146 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190610-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR