BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6272045 · Received January 23, 2017

    Report

    Report Number
    3005862821-2017-00010
    Event Type
    Injury
    Date Received
    January 23, 2017
    Date of Event
    December 23, 2016
    Report Date
    December 23, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    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 11/06/2015. ACCORDING TO REPORTER'S DESCRIBE,THE SUSPECTED STRIP LOT #D111223-1, WHICH WAS MANUFACTURED ON 12/23/2011 AND EXPIRED ON 12/23/2013. PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2016 AT 8:30 PM AFTER THE END USER RECEIVED A READING OF "HI" FROM THE PRODIGY DIABETES GLUCOSE MONITOR DEVICE. IT WAS DETERMINED THAT THE END USER WAS USING EXPIRED TEST STRIPS. THE END USER EXPERIENCED BLURRY VISION AND FELT NAUSEATED. HIS BLOOD GLUCOSE READING AT THE TIME OF THE MEDICAL EVENT WAS "HI." THE PARAMEDICS WERE CALLED AND PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 364 MG/DL THE END USER WAS GIVEN AN IV FLUID AND TRANSPORTED TO THE ER. UPON ARRIVAL TO THE ER THE END USER HAD A BLOOD GLUCOSE READING OF 246 MG/DL. HE WAS ADMINISTERED ADDITIONAL IV FLUIDS TO STABILIZE HIS BLOOD GLUCOSE LEVELS. UPON DISCHARGE THE END USER'S BLOOD GLUCOSE WAS 320 MG/DL AND WAS INSTRUCTED TO FOLLOW UP WITH HIS PCP. NO FURTHER DETAILS WERE PROVIDED IN REGARDS TO THE MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52913 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D111223-1

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention AMBIEN| ASPIRIN| BUPROPION| FAMOTIDINE| FISH OIL| GABAPENTIN| HUMULIN R U500| HYDROCODONE| LISINOPRIL| MECLOZINE| METOCLOPRAMIDE| NIACIN| NITROGLYCERIN| PRISTIQ| PROTONIX| SENOSIBRATE| VITAMIN D