BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 12538641 · Received September 28, 2021

    Report

    Report Number
    3005862821-2021-00016
    Event Type
    Injury
    Date Received
    September 28, 2021
    Date of Event
    July 25, 2021
    Report Date
    August 25, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO NONCONFORMANCE WAS FOUND AND RECORDED IN THE DOCUMENT ((B)(4)) AFTER OKB REVIEWED DEVICE HISTORY RECORD (DHF) OF THE SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D200226-1). THE METER THAT WAS SHIPPED TO PDC ON (B)(6) 2016 AND THE RETAINED ONE (SERIAL#: (B)(4)) WERE USED TO RE-EXAMINED THEIR SETTING AND ALL FUNCTIONS, AND NO MALFUNCTION OF BOTH METERS OCCURRED. STANDBY CURRENT (4.5 UA) OF THE RETURN METER MET ACCEPTANCE CRITERIA (< 55 UA). STRIPS WERE MANUFACTURED ON 02-26-2020 AND WILL EXPIRE IN 02-2022. RETURN AND RETAINED STRIPS (LOT#: D200226-1) WERE RE-TESTED BY USING RETURN AND RETAINED METERS WITH ANY VALID CONTROL SOLUTIONS (BATCH# OF LEVEL LOW: 9AH1A02 AND EXP. BY 02-2022; BATCH# OF LEVEL HIGH: 0AH3A17 AND EXP. BY 12-2022), RESPECTIVELY. RE-TESTING RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA(LEVEL LOW: 30~80 ; LEVEL HIGH: 220~330), AND DESICCANTS OF BOTH STRIP VIALS ARE STILL FUNCTIONAL (ORANGE COLOR). RETURN METER W/ RETURN STRIPS: 55/61 (LEVEL LOW) AND 269/266 (LEVEL HIGH) RETURN METER W/ RETAINED STRIPS: 62/62 (LEVEL LOW) AND 272/265 (LEVEL HIGH) RETAINED METER W/ RETURN STRIPS: 59/59 (LEVEL LOW) AND 287/263 (LEVEL HIGH) RETAINED METER W/ RETAINED STRIPS: 63/61 (LEVEL LOW) AND 289/279 (LEVEL HIGH) . AS ABOVE, NO NON-CONFORMANCE AND MALFUNCTION OF THE SUSPECTED ITEMS WERE FOUND. THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE VERIFIED WITHOUT MORE CRITICAL INFORMATION. THEREFORE, THE COMPLAINT HAS TO BE CLOSED OUT IF NO FURTHER ACTION AND INFORMATION FROM THE USER.

    Description of Event or Problem · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2021 AROUND 5:00PM AT HOME. CALLER STATED THAT THE END-USER TESTED HIS BLOOD GLUCOSE WITH HIS PRODIGY METER AND RECEIVED A RESULT OF 81MG/DL. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 130MG/DL. THE END-USER CURRENTLY TAKES HUMALOG INSULIN: 10 UNITS BEFORE BREAKFAST, 15 UNITS BEFORE LUNCH, 10 UNITS BEFORE DINNER LANTUS INSULIN: 5 UNITS AT BEDTIME. HE IS NOT ON A SLIDING SCALE. THE END-USER PERFORMED AN ADDITIONAL BLOOD GLUCOSE TESTS WITH HIS PRODIGY METER AND RECEIVED A RESULT OF 209MG/DL. THE CALLER STATED THAT THE END-USER WAS ACTING IRRATIONAL AND VOMITING AND HAD CLAMMY SKIN. THE CALLER STATED THEY DIDN'T CALL EMS THE END-USER WAS TAKEN TO (B)(6) HOSPITAL, (B)(6). THE END-USERS BLOOD GLUCOSE UPON ARRIVING AT THE HOSPITAL WAS 96MG/DL. THE END-USER TOOK HUMALOG, AND ATE A MEAL OF PORK CHOP, MIXED VEGETABLES, AND CORNBREAD PRIOR TO GOING TO THE HOSPITAL. THE END-USER WAS PUT ON A GLUCOSE IV DUE TO TESTING HIS BLOOD GLUCOSE AGAIN AT THE HOSPITAL AND RECEIVING A RESULT OF 27MG/DL. THE CALLER STATED THAT THE END-USER HAD A EKG BLOOD WORK AND A CHEST X-RAY WHILE AT THE HOSPITAL. THE END-USER WAS AT THE HOSPITAL FOR 5 HOURS AND WAS DISCHARGED WITH A BLOOD GLUCOSE OF 130MG/DL. THE END-USER WAS TOLD TO FOLLOW UP WITH HIS PRIMARY DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437616 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D200226-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization ASCORBIC ACID 500MG| ELIQUIS 2.5MG| ENVARSUS 1MG| ENVARSUS XR 0.75MG| FERROUS SULFATE 325MG| FLOMAX 0.4MG| HUMALOG| IMURAN 25MG| LANTUS| LIPITOR 80MG| METOPROLOL 25MG| MULTI-VITAMIN| PLAVIX 75MG| PREDNISONE 5MG| PRILOSEC 20MG| REMERON 7.5MG| SODIUM BICARBONATE 650MG| VITAMIN D| ZINC SULFATE 220MG