BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6685480 · Received July 4, 2017

    Report

    Report Number
    3005862821-2017-00058
    Event Type
    Injury
    Date Received
    July 4, 2017
    Date of Event
    February 28, 2017
    Report Date
    June 2, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.5A. THE CRITERIA IS <55A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER: D150810-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 63/65 MG/DL, FOR LEVEL HIGH WERE 279/270 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN OF THE ACCEPTANCE RANGE. PASS . WE TESTED THE SUSPECTED METER WITH RETAIN STRIPS IN OUR WAREHOUSE (SAME PATIENT'S STRIP LOT NUMBER: D150810-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 65/68 MG/DL; FOR LEVEL HIGH WERE 279/281 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Additional Manufacturer Narrative · 1

    BECAUSE DEVICE WAS NOT RETURNED TO OK BIOTECH, THEREFORE, WE WERE UNABLE TO PERFORM FURTHER TESTING ON THE SUSPECTED DEVICE. OK BIOTECH REVIEWED THE MANUFACTURING RECORD OF THIS SUSPECTED DEVICE (METER SERIAL NUMBER # (B)(4)), AND THE METER WAS QUALIFIED AND RELEASED BY THE QUALITY CONTROL DEPARTMENT AND SHIPPED TO (B)(4) ON 12/28/2011. WE ARE UNABLE TO CONFIRM THE COMPLAINT BECAUSE DEVICE WAS NOT RETURNED AND NO FURTHER INFORMATION FROM CUSTOMER HAS BEEN RECEIVED, THIS MATTER HAS TO BE CLOSED OUT WITH UNDETERMINED ROOT CAUSE.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00058 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON (B)(6) AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT (B)(6) 2017 AT 9:30 PM AFTER THE END USER WAS RECEIVING HIGHER THAN NORMAL BLOOD GLUCOSE READINGS FROM HER PRODIGY DIABETES METER. THE END USER RECEIVED A BLOOD GLUCOSE READING OF 425 MG/DL AND THE PARAMEDICS WERE CALLED. THE PARAMEDICS PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 135 MG/DL. NO TREATMENT WAS ADMINISTERED NOR WAS THE END USER TRANSPORTED TO THE ER DUE TO HER BLOOD GLUCOSE READING WAS WITHIN THE NORMAL RANGE AND DID NOT WARRANT ANY FURTHER ACTIONS. NO ADDITIONAL DETAILS WERE PROVIDED IN RELATIONS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465933 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D150810-2

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention ALLOPURINOL 100 MG 1 TABLET IN THE MORNING| ALPRAZOLAM 1 MG A TABLET 3 TIMES A DAY| COLCHICINE 0.6 1 TABLET IN THE MORNING| FERROUS SULFATE 325/65 MG ONE AT BEDTIME| FUROSEMIDE 20 MG 1 TABLET IN THE MORING| JANUVIA 100 MG 1 TABLET IN THE MORNING| LEVOTHYROXINE 0.01 MG 1 TABLET IN THE MORNING| NORTRIPTYLINE 50 MG 1 TABLET AT BEDTIME| OMEPRAZOLE 20 MG 1 AT BEDTIME| SIMVASTATIN 20 MG 1 TABLET AT NIGHT| TRAVATAN Z 0.004% ONE DROP IN EACH EYE AT BEDTIME| VALSARTAN 320 MG 1 TABLET IN THE MORNING