BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9961291 · Received April 15, 2020

    Report

    Report Number
    3005862821-2020-00017
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    February 29, 2020
    Report Date
    March 17, 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#: D181025-2). RETURN AND RETAINED STRIPS (LOT#: D181025-2) 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 WERE SHOWN BELOW. 2.1 RETURN METER W/ RETURN STRIPS: 128*/128* (LEVEL LOW) AND 307/287 (LEVEL HIGH). 2.2 RETURN METER W/ RETAINED STRIPS: 73/74 (LEVEL LOW) AND 273/263 (LEVEL HIGH). 2.3 RETAINED METER W/ RETURN STRIPS: 129*/150* (LEVEL LOW) AND 308/335* (LEVEL HIGH) . 2.4 RETAINED METER W/ RETAINED STRIPS: 74/74 (LEVEL LOW) AND 263/271 (LEVEL HIGH). 3. DESICCANTS OF RETAINED STRIPS FROM OKB'S WAREHOUSE WERE STILL FUNCTIONAL (ORANGE COLOR), AND TESTING RESULTS ABOVE MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 30~80; LEVEL HIGH: 200~310). HOWEVER, DESICCANTS OF RETURN STRIPS FROM THE CLIENT WERE INEFFECTIVE (GREEN COLOR), AND TESTING RESULTS ABOVE WERE FAILED (HIGHLIGHTED AS "*"). ABNORMAL HIGH RESULTS WERE OBTAINED BECAUSE STRIPS HAVE GOT DAMP. WARNING INFORMATION REGARDING CLOSE THE VIAL LID OF STRIPS IMMEDIATELY WAS DISCLOSED IN USER'S MANUAL, STRIP BOX AND LABELING, VIAL LABEL AND OUTSIDE SURFACE OF THE LID OF STRIP BOTTLE. THEREFORE, USER'S IMPROPER OPERATION AND PRESERVATION MOSTLY CAUSED THE MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 4:00/4:30PM AT HOME. CALLER STATED THAT THE END-USER APPEARED CONFUSED AND WAS UNABLE TO WALK. HER BLOOD GLUCOSE WAS TESTED, AND THEY RECEIVED A RESULT OF 149.MG/DL. CALLER STATED THE END-USER TESTS 3 TIMES A DAY AND A NORMAL RESULT FOR THAT TIME OF DAY IS AROUND 200MG/DL. CALLER THEN TOOK THE END-USER TO THE EMERGENCY ROOM. NO FOOD DRINK OR MEDICATIONS WERE CONSUMED PRIOR TO GOING TO THE HOSPITAL. UPON ARRIVING AT THE HOSPITAL, THE END-USERS BLOOD GLUCOSE WAS 34MG/DL. THE END-USER WAS GIVEN AN IV WITH AS GLUCOSE SOLUTION TO LOWER HER BLOOD GLUCOSE LEVELS. THE END-USER WAS NOT GIVING ANY OTHER TREATMENTS. CALLER STATED THAT THE END-USER HAD A BLOOD GLUCOSE OF 147MG/DL PRIOR TO BEING DISCHARGED. THE END-USER WAS TREATED AT (B)(6). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426932 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D181025-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization