BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7380636 · Received March 29, 2018

    Report

    Report Number
    3005862821-2018-00026
    Event Type
    Injury
    Date Received
    March 29, 2018
    Date of Event
    March 3, 2018
    Report Date
    March 5, 2018
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. OK BIOTECH TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 1.2A. 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 IN HOUSE STRIPS (STRIP LOT NUMBER: D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 68/63 MG/DL, FOR LEVEL HIGH WERE 250/242 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~300 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. ACCORDING TO IMPORTER'S REPORT, PATIENT USED THE EXPIRED STRIPS(STRIP LOT NUMBER: D151222-2). WE TOOK THE RETAIN STRIPS (SAME BATCH) FROM OUR WAREHOUSE AND TESTED WITH RETURNED METER AND IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 321/400 MG/DL; FOR LEVEL HIGH WERE 501/472 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE OUT OF THE ACCEPTANCE RANGE. PATIENT'S STRIP WAS MANUFACTURED ON 12/22/2015 AND EXPIRED ON DEC 22, 2017. PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO HIGHER READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2018 AT 7:00 PM AFTER THE END USER ALLEGED THAT SHE RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HER PRODIGY DIABETES METER. IT WAS ALSO DISCOVERED THAT THE END USER WAS USING EXPIRED TEST STRIPS WHICH COULD ATTRIBUTE TO A FLUCTUATION IN BLOOD GLUCOSE READINGS. THE END USER EXPERIENCED DIZZINESS ACCOMPANIED WITH A BLOOD GLUCOSE RESULT OF "HI" AND SHE PROCEEDED TO TAKE METFORMIN TO ASSIST IN LOWERING HER READING. TWO ADDITIONAL BLOOD GLUCOSE TEST WERE PERFORMED WITH THE FOLLOWING RESULTS - 408 MG/DL AND 524 MG/DL. SUBSEQUENTLY THE END USER WAS TAKEN TO THE ER AND UPON ARRIVAL A BLOOD GLUCOSE TEST WAS PERFORMED WITH THE HOSPITALS METER AND THE RESULT WAS 131 MG/DL. TREATMENT WAS ADMINISTERED BUT THE END USER COULD NOT RECALL AS TO WHAT WAS GIVEN. AFTER 6 HOURS IN THE ER THE END USER WAS DISCHARGED WITH INSTRUCTIONS TO FOLLOW-UP WITH HER PCP. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224173 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 54800 - D151222-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention GABAPENTIN| METFORMIN| RAMIPRIL