BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 15630267 · Received October 19, 2022

    Report

    Report Number
    3005862821-2022-00009
    Event Type
    Injury
    Date Received
    October 19, 2022
    Date of Event
    September 4, 2022
    Report Date
    October 14, 2022
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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#: D170612-1). THE SUSPECTED METER THAT WAS SHIPPED TO PDC ON 2017-06-14 AND THE RETAINED ONE (SERIAL#: (B)(4)) WERE USED TO RE-EXAMINE THEIR SETTING AND ALL FUNCTIONS, AND NO MALFUNCTION OCCURRED. STANDBY CURRENT (1.4 UA) OF THE SUSPECTED METER MET ACCEPTANCE CRITERIA (< 55 UA). SUSPECTED STRIPS (LOT#D170612-1) WITH 2-YEAR SHELF LIFE WERE EXPIRED ON 2019-06-12. BECAUSE THEY WERE EXPIRED AND OUT OF SPECIFICATIONS, THE SUSPECTED METER WAS TESTED BY USING ANY RETAINED STRIPS (LOT#: D210611B-1) FROM OKB'S WAREHOUSE AND CONTROL SOLUTIONS (BATCH# OF LEVEL LOW: 0AH1A03 AND EXP. BY 2022-12-31; BATCH# OF LEVEL HIGH: 0AH3A17 AND EXP. BY 2022-12-31). RE-TESTING RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA, AND DESICCANTS OF THE STRIP VIAL ARE FUNCTIONAL (ORANGE COLOR). TEST RESULTS (LEVEL LOW: 70/68; LEVEL HIGH: 308/318) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 30~75; LEVEL HIGH: 230~340). 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 · 0

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2022 AROUND 11:00AM AT HOME. CALLER STATED THAT THE END-USER TESTED HIS BLOOD GLUCOSE WITH HIS PRODIGY METER AND RECEIVED A RESULT OF 240MG/DL. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 102MG/DL. THE CALLER STATED THAT THE END-USER IS ON A SLIDING SCALE AS FOLLOWS: 25 UNITS ONLY BEFORE BEDTIME FIVE UNITS 3 TIMES PER DAY WITH HUMALOG ON A SLIDING SCALE. ABOUT 15 MINUTES AFTER TESTING THE PARAMEDICS WERE CALLED DUE TO THE END-USER BEING FATIGUED AND SWEATY. NO MEDICATION WERE CONSUMED. THE END-USER HAD STRUDEL, SAUSAGE, AND ORANGE JUICE WHILE WAITING FOR PARAMEDIC TO ARRIVE. PARAMEDICS ARRIVED IN ABOUT 5 MINUTES. THE PARAMEDICS TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 72MG/DL. PARAMEDICS ALSO TESTED THE END-USERS BLOOD GLUCOSE WITH HIS PRODIGY METER AND RECEIVED A RESULT OF 202MG/DL. THE CALLER STATED THAT THE END-USER WAS GIVEN A GLUCOSE SOLUTION TO LOWER HIS BLOOD GLUCOSE AND HE WAS NOT TRANSPORTED TO THE HOSPITAL. THE CALLER WAS INFORMED THAT THE END-USERS TEST STRIPS ARE EXPIRED AND WAS EDUCATED TO ALWAYS DISCARD EXPIRED PRODUCTS. PRIOR TO SEEKING MEDICAL ATTENTION THE END-USER HAD HIS INSULIN CHANGED FROM 30 UNITS TO 25 UNITS. NONADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2943985 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D170612-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male ATORVASTATIN.| HUMALOG.| LANTUS.| MIDODRINE.| SERTRALINE HCL.| WARFARIN.