BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 11221696 · Received January 25, 2021

    Report

    Report Number
    3005862821-2021-00002
    Event Type
    Injury
    Date Received
    January 25, 2021
    Date of Event
    December 6, 2020
    Report Date
    December 30, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. THE CASE WITH REFERENCE TO IMPORTER'S MDR (#: 3008789114-2020-00062) WAS RECEIVED AT 01-06-2021 AND ITS INITIAL INVESTIGATION WAS COMPLETED AT 01-14-2021. THE ROOT CAUSE WAS USER'S IMPROPER OPERATION WITH EXPIRED STRIPS (LOT#: D180619-1). THE OTHER SUSPECTED DEVICE INCLUDING STRIPS (LOT#: D200106-4) AND THE METER WERE OBTAINED AND INVESTIGATED HERE. 2. NO NON-CONFORMANCE WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED DEVICE (METER SERIAL#: (B)(6) AND STRIP LOT#: D200106-4). 3. RETURN AND RETAINED STRIPS (LOT#: D200106-4) WERE RE-TESTED BY USING RETURN (SERIAL#: (B)(6) AND RETAINED (SERIAL#: (B)(6) 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: 45~95 ; LEVEL HIGH: 250~360). 3.1 RETURN METER W/ RETURN STRIPS: 68 (LEVEL LOW) AND 323 (LEVEL HIGH). 3.2 RETURN METER W/ RETAINED STRIPS: 79/76 (LEVEL LOW) AND 284/310 (LEVEL HIGH). 3.3 RETAINED METER W/ RETURN STRIPS: 69 (LEVEL LOW) AND 303 (LEVEL HIGH). 3.4 RETAINED METER W/ RETAINED STRIPS: 76/76 (LEVEL LOW) AND 320/330 (LEVEL HIGH). 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). 5. 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 · 0

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2021-00002 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON (B)(6) 2021 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Additional Manufacturer Narrative · 1

    NO NON-CONFORMITY WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D180619-1). THE METER WAS SHIPPED TO PDC ON 08/25/2016. STRIPS WERE MANUFACTURED ON 06/19/2018 AND WERE EXPIRED IN 06/2020. BECAUSE THE SUSPECTED BGMS WAS NOT RETURNED TO OKB, THE RETAINED DEVICE (SERIAL#: (B)(4)) WAS USED TO RE-TEST, AND THE COMPLAINT SITUATIONS DID NOT OCCUR. ALSO, THE SUSPECTED STRIPS WERE EXPIRED AND OUT OF SPECIFICATIONS. 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 (B)(6) 2020 AROUND 4:00PM AT HOME. END-USER STATED THAT SHE TESTED HER BLOOD GLUCOSE AND RECEIVED A RESULT OF 315MG/DL. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 130-147MG/DL. END-USER STATED THAT SHE STARTED TO FEEL SHAKY AND FATIGUED ABOUT 15-20 MINUTES AFTER TESTING AND SHE CALLED PARAMEDICS. THE END-USER STATED THAT SHE DRANK WATER AND TOOK A GLUCOSE PILL WHILE WAITING FOR PARAMEDICS WHO ARRIVED WITHIN 10 MINUTES. PARAMEDICS TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 46MG/DL. THE ENDUSER STATED THAT SHE DID NOT RECEIVE ANY TREATMENT FROM THE PARAMEDICS BUT THAT THEY TRANSPORTED HER TO ASCENSION (B)(6) HOSPITAL LOCATED AT (B)(6). UPON ARRIVING AT THE HOSPITAL, THE END-USERS BLOOD GLUCOSE WAS 46MG/DL. THE END-USER STATED THAT SHE WAS GIVEN GLUCOSE THROUGH AN IV AND ORANGE JUICE TO RAISE HER BLOOD GLUCOSE LEVELS. THE END-USER WAS USING EXPIRED TEST STRIPS AND WAS ADVISED TO DISCARD ANY EXPIRED PRODUCTS. END-USER ALSO DECLINED TO GIVE ANY OTHER MEDICATIONS OTHER THAN HER INSULIN. THAT SHE TAKES AS FOLLOWS LANTUS: 22 UNITS PER DAY, NOVOLOG: 7 UNITS PER DAY. THE END-USER STATED THAT WHEN SHE WAS DISCHARGED FROM THE HOSPITAL HER BLOOD GLUCOSE WAS 109MG/DL. NO DISCHARGE INSTRUCTIONS WERE PROVIDED ANDS SHE STATED THAT HAS HAD NO CHANGES TO HER MEDICATION BEFORE OR AFTER SEEKING MEDICAL ATTENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123982 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D200106-4 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization LANTUS.| NOVOLOG.