BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6342056 · Received February 18, 2017

    Report

    Report Number
    3005862821-2017-00015
    Event Type
    Injury
    Date Received
    February 18, 2017
    Date of Event
    January 21, 2017
    Report Date
    January 21, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 THE RETURNED METER, THE RESULT WAS 1.0¿A. THE CRITERIA IS <55¿A. 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 55/51 MG/DL, FOR LEVEL HIGH WERE 248/238 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. BECASUE PATIENT DID NOT RETURN HER STRIPS, SO WE TESTED THE RETAIN STRIPS IN OUR WAREHOUSE (SAME STRIP LOT AS PATIENT'S STRIP, LOT NUMBER: D150820-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 59/64 MG/DL, FOR LEVEL HIGH WERE 273/270 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2007 AT 4:00 AM AFTER THE END USER RECEIVED INACCURATE RESULTS FROM THE PRODIGY DIABETES GLUCOSE METER. THE END USER RECEIVED A RESULT OF 147 MG/DL AND BECAME UNRESPONSIVE. THE PARAMEDICS WERE CALLED AND TRANSPORTED THE END USER TO THE ER. UPON ARRIVAL TO THE ER THE END USER'S BLOOD GLUCOSE WAS 60 MG/DL. SHE WAS ADMINISTERED IV FLUIDS ALONG WITH ORANGE JUICE, HAM/CHEESE SANDWICH, PUDDING AND SHASTA SODA TO ASSIST WITH STABILIZING HER BLOOD GLUCOSE LEVELS. UPON DISCHARGE FROM THE ER HER BLOOD GLUCOSE WAS 150 MG/DL. NO FURTHER DETAILS WERE PROVIDED IN RELATIONS TO THE MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124810 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D150820-1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention ALFUZOSIN 10MG ONCE A DAY| ALLOPURINOL 300MG 1 A DAY| CELEBREX 200 MG ONCE DAILY| CELEXA 40 MG 1 DAILYCELEXA 40 MG 1 DAILY| CHLORPHENIRAMINE POLISTIREX PENNKINETIC| FLONASE NASAL SPRAY USP 50 MCG 2 SPRAYS DAILY| GABAPENTIN 100MG/DL AS NEEDED BREAKTHROUGH PAIN| GABAPENTIN 400 MG 4 TIMES DAILY| HYDROCODONE POLISTIREX| HYDROCORTISONE CREAM 2.5% AS NEEDED| INVOKANA 300MG IN AM| JANUMET 50MG/1000MG IN AM/PM| LASIX 80 MG ONCE A DAY| MONTELUKAST 20MG DAILY| POTASSIUM CHLORIDE 10MEQ ER 4 DAILY| PRILOSEC 20 MG ONCE A DAY| PROPYLENE GLYCOL 0.3%) AS NEEDED| SPIRIVA 1 CAPSULE ONCE A DAY| SULFAMETHOXAZOLE AND TRIMETHOPRIM 400/80 TAB DAILY| SYMBICORT INHALER 160/4.5 IN AM/PM| SYSTANE EYE DROPS (POLYETHYLENE GLYCOL 400 0.4%| TESSALON PERLES 300MG ONCE DAILY| TOPAMAX 25MG 1 TAB 3XS DAILY| VENTOLIN HFA (ALBUTEROL SULFATE) 90MCG/ACTUATION| VESICARE 5MG EVERY 12 HOURS| VISTARIL (HYDROXYZINE) HCL 5MG 1-2 EVERY 8 HOURS| XANAX 1MG 4 DAILY| ZANAFLEX 4MG 2 TABS 2XS A DAY