BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5924111 · Received September 2, 2016

    Report

    Report Number
    3005862821-2016-00063
    Event Type
    Injury
    Date Received
    September 2, 2016
    Date of Event
    July 9, 2016
    Report Date
    July 18, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. THE STANDBY CURRENT TEST IS 1.5¿A. THE CRITERIA IS <55¿A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETAIN STRIPS (STRIP LOT NUMBER:D151218-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 52/50 MG/DL; FOR LEVEL HIGH ARE 256/253 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. PATIENT ALSO SENT BACK THE SUSPECTED STRIPS(STRIP LOT NUMBER:D151218-1). WE TESTED THE RETURNED STRIP WITH IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 52/52 MG/DL; FOR LEVEL HIGH WERE 240/242 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.

    Description of Event or Problem · 1

    OUR IMPORTER, (B)(4) RECEIVED A CALL ON 07/18/2016 REPORTING A MEDICAL INTERVENTION THAT OCCURRED ON (B)(6) 2016 AT 9:00PM. PATIENT(PR) CALLED IN STATING THAT HER METER WAS NOT GIVING THE CORRECT RESULTS. PR WAS EXPERIENCING SYMPTOMS OF SHAKING, SWEATING AND VOMITING. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 96MG/DL. PR HAD NOT TAKEN ANY MEDICATIONS PRIOR THE SEEKING MEDICAL ATTENTION BUT DID CONSUME SUGAR FREE (B)(6) WITH MIXED FRUIT. THREE (3) ADDITIONAL GLUCOSE TESTS WERE PERFORMED WITH RESULTS OF 90, 88 AND 70MG/DL. PR'S NORMAL BLOOD GLUCOSE READING AROUND THE TIME OF DAY OF THE EVENT IS 80-100MG/DL. PARAMEDICS WERE CALLED 30 MINUTES AFTER TESTING WITH THE PRODIGY METER AND ARRIVED 30 MINUTES AFTER BEING CALLED. UPON ARRIVAL PARAMEDICS TESTED PR'S GLUCOSE WITH THEIR METER WITH A RESULT OF 161MG/DL. APPROXIMATELY 1 HOUR PASSED BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDIC'S METER. PR WAS TRANSPORTED TO ER BY PARAMEDIC'S AND GIVEN A SHOT OF ZOFRAN FOR HER NAUSEA. PR DID NOT RECALL WHAT HER GLUCOSE LEVEL WAS PRIOR TO RELEASE FROM THE HOSPITAL, ONLY THAT IT WAS LOW. PR'S TOTAL STAY IN HOSPITAL WAS 3 DAYS. PRODIGY SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576773 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D151218-1

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention BACLOFEN 20MG 2X A DAY| ENALAPRIL 2.5 MG 1X A DAY| GABAPENTIN 100MG 2X A DAY| HUMALOG 45 UNITS| HYDROMORPHONE 2MG 4X A DAY| LANTUS 71 UNITS| METFORMIN 1000MG 2X A DAY| THYROXINE 10MG 1X ADAY