BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9748778 · Received February 25, 2020

    Report

    Report Number
    3005862821-2020-00009
    Event Type
    Injury
    Date Received
    February 25, 2020
    Date of Event
    January 17, 2020
    Report Date
    February 5, 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#: D190201-2). METER SETTING AND ALL FUNCTIONS OF THE SUSPECTED DEVICE WERE RE-TESTED, AND ALL OF THEM WERE OPERATED PROPERLY. STANDBY CURRENT AND PERFORMANCE OF THE SUSPECTED DEVICE (SERIAL#: (B)(4)) WERE RE-CHECKED. THE CURRENT (1.8 UA) MET ACCEPTANCE CRITERIA (< 55 UA) AND PERFORMANCE TESTING WAS QUALIFIED BY USING ELECTRONIC STRIPS (100 & 200 K). STRIPS WERE MANUFACTURED ON 02/01/2019 AND WILL EXPIRE IN 02/2021. RETAINED AND RETURN STRIPS (LOT#: D190201-2) WERE RE-TESTED BY USING RETAINED METER (SERIAL#: (B)(4)) AND CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A94, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A14, EXP. BY SEPT., 2020). DESICCANTS OF RETAINED STRIPS (LOT#: D181031-2) WERE STILL FUNCTIONAL (ORANGE COLOR), AND TESTING RESULTS (LEVEL LOW: 64/66; LEVEL HIGH: 241/235) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85; LEVEL HIGH: 200~310). HOWEVER, THE COLOR OF DESICCANTS OF RETURN STRIPS WAS CHANGED TO GREEN COLOR THAT INDICATED SUSPECTED ONES GOT DAMP, AND TESTING RESULTS (LEVEL LOW: 117/103; LEVEL HIGH: 254/298) WERE OUT OF SPECIFICATIONS (LEVEL LOW: 35~85; LEVEL HIGH: 200~310), TOO. NEVERTHELESS, WARNING INFORMATION REGARDING CLOSE THE VIAL LID OF STRIPS IMMEDIATELY WAS STATED 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 6:00PM AT HOME. CALLER STATED THAT THE END-USER TESTED HER BLOOD GLUCOSE AND RECEIVED A RESULT OF 235MG/DL. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 130-140MG/DL. THE END-USER TOOK HER 15 UNIT OF LANTUS BASED ON HER RESULT. ABOUT 45 MINUTES LATER THE END-USER WAS SLURRING HER WORDS AND WAS UNSTABLE I.E. FALLING. EMS WERE CALLED. NO FOOD DRINK OR MEDICATION WAS CONSUMED WHILE WAITING FOR EMS TO ARRIVE. EMS ARRIVED WITHIN 2 MINUTES AND TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND GOT A RESULT OF 35MG/DL. EMS GAVE THE END-USER A GLUCOSE SOLUTION BY MOUTH. EMS DID NOT TRANSFER THE END-USER TO THE HOSPITAL. PRIOR TO THE EMS LEAVING THEY PERFORMED ANOTHER BLOOD GLUCOSE TEST WITH THEIR METER AND GOT A RESULT OF 85MG/DL AND ADVISED THE END-USER TO FOLLOW UP WITH HER PRIMARY DOCTOR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214263 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190201-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR