BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10107509 · Received June 1, 2020

    Report

    Report Number
    3005862821-2020-00029
    Event Type
    Injury
    Date Received
    June 1, 2020
    Date of Event
    April 29, 2020
    Report Date
    May 15, 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#: D190223-2). RETURN AND RETAINED STRIPS (LOT#: D190223-2) 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. RETURN METER W/ RETURN STRIPS: 148/139 (LEVEL LOW) AND 331/333 (LEVEL HIGH). RETURN METER W/ RETAINED STRIPS: 65/62 (LEVEL LOW) AND 252/243 (LEVEL HIGH). RETAINED METER W/ RETURN STRIPS: 154/151 (LEVEL LOW) AND 339/338 (LEVEL HIGH) . RETAINED METER W/ RETAINED STRIPS: 73/67 (LEVEL LOW) AND 259/257 (LEVEL HIGH) . DESICCANTS OF RETAINED STRIPS FROM OKB'S WAREHOUSE WERE STILL FUNCTIONAL (ORANGE COLOR), AND TESTING RESULTS ABOVE MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85; LEVEL HIGH: 200~310). HOWEVER, DESICCANTS OF RETURN STRIPS FROM THE CLIENT WERE INEFFECTIVE (GREEN COLOR), AND TESTING RESULTS ABOVE WERE FAILED. 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 11:00AM AT HOME. CALLER STATED THAT THE END-USER STARTED SWEATING AND WAS INCOHERENT, SO THE CALLER PERFORMED A BLOOD GLUCOSE TEST WITH THE PRODIGY METER, THE METER READ 121MG/DL. THE CALLER DOES NOT KNOW WHAT A NORMAL RESULT WOULD BE FOR THE END-USER AROUND THAT TIME OF DAY. THE CALLER FELT THAT THE READING FORM THE PRODIGY METER WAS INCORRECT, SO THEY CONTACTED THE PARAMEDICS. NO FOOD DRINK OR MEDICATIONS WERE TAKEN WHILE WAITING FOR PARAMEDICS TO ARRIVE. PARAMEDICS ARRIVED WITHIN 5 MINUTES AND TESTED THE ENDUSERS BLOOD GLUCOSE TEST WITH THEIR METER AND GOT A RESULT OF 36MG/DL. THE PARAMEDICS GAVE THE END-USER GLUCOSE THROUGH THE IV. THE END-USER WAS NOT TRANSPORTED TO THE HOSPITAL BY PARAMEDICS AND HE DID NOT GO ON HIS OWN. WHEN THE IV FINISHED THE PARAMEDICS CHECKED THE END-USER BLOOD GLUCOSE HOWEVER THE CALLER DOES NOT RECALL WHAT THE RESULT WAS. THE END-USER TAKES INSULIN AS FOLLOWS: LEVEMIR 15 UNITS A DAY NOVOLOG 7 UNITS A DAY + SLIDING SCALE: LESS THAN 139MG/DL JUST 7 UNITS. OVER 139MG/DL +1 UNIT PER 10MG/DL ADDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571196 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190223-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention