BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6244996 · Received January 12, 2017

    Report

    Report Number
    3005862821-2017-00004
    Event Type
    Injury
    Date Received
    January 12, 2017
    Date of Event
    December 4, 2016
    Report Date
    December 4, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 1.1UA, THE CRITERIA IS <55UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETAIN STRIPS (SAME BATCH OF THIS REPORTED STRIP, LOT NUMBER: D160127-2). THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 52/49 MG/DL, FOR LEVEL HIGH ARE 235/240 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. BECAUSE PATIENT DID NOT RETURN STRIPS, AND ACCORDING TO OUR MANUFACTURING RECORD, THIS STRIP LOT #D160127-2 WAS MANUFACTURED ON 01/27/2016 AND EXPIRED IN 01/2018. OK BIOTECH RECEIVED 1 COMPLAINT FROM SAME MANUFACTURING BATCH OF STRIPS ON DEC. 05, 2016 BECAUSE OF ABSORBANCE SPEED SLOW AFTER APPLIED BLOOD INTO STRIP. BUT THE COMPLAINT OF THIS INITIAL REPORT WAS FOR HIGH READING, WHICH WAS NOT RELATED TO ABSORBANCE PROBLEM. WE ARE UNABLE TO CONFIRM THE COMPLAINT BECAUSE DEVICE WAS CHECK AND FOUND WITHIN OUR SPECIFICATION AND NO RETURNED STRIP FROM PATIENT, THIS MATTER HAS TO BE CLOSED OUT WITH UNDETERMINED ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER SOUGHT MEDICAL ATTENTION ON (B)(6) 2016 BETWEEN 5:00 - 6:00PM AFTER RECEIVING A HIGH READING OF 596 MG/DL FROM THE PRODIGY DIABETES GLUCOSE METER. THE END USER WAS EXPERIENCING FREQUENT URINATION, CONFUSION AND LETHARGIC. THE END USER WENT TO THE ER AND UPON ARRIVAL HIS BLOOD GLUCOSE READING WAS CLOSE TO 500 MG/DL. HE WAS ADMITTED TO THE HOSPITAL FOR A LENGTH OF FOUR DAYS. TO LOWER HIS GLUCOSE LEVELS INSULIN AND IV FLUIDS WERE ADMINISTERED ALONG WITH MAGNESIUM. UPON DISCHARGE HIS BLOOD GLUCOSE WAS 170 MG/DL AND HE WAS INSTRUCTED TO FOLLOW-UP WITH HIS PCP AND MAINTAIN A CLEAR CHART OF HIS BLOOD GLUCOSE READINGS. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28291 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160127-2

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R AMLODIPINE BESYLATE 10MG 1 TABLET AT BEDTIME| CALCIUM MAGNESIUM 500/250MG DAILY IN THE MORNING| CLONIDINE (CATAPRES) 0.1MG AT BEDTIME| COREG 6.25MG TWICE A DAY| ELIQUIS 2.5MG 2 DAILY| HYZAAR 100-25MG 1 IN THE MORNING| IMDUR 30MG 1 IN THE MORNING| KEPPRA 750MG TWICE A DAY| LANTUS| LANTUS 40 UNITS AM AND 40 UNITS PM| LIPITOR 80MG 1 TABLET AT BEDTIME| METFORMIN 1000MG/DL 1 TABLET TWICE DAILY| MYRBETRIQ 50MG 1IN THE MORNING| NOVOLOG| PLAVIX 75MG 1 IN THE MORNING| POTASSIUM CHLORIDE 20 MEQ 1 AT BEDTIME| PROBIOTIC 25 BILLION| PROTONIX 40MG ONE IN THE MORNING| SUPER OMEGA-3 1000MG| VERAPAMIL 220MG/DL 1 IN THE MORNING| VITAMIN D3 K2 1000 IU| ZOLOFT 100MG ONE AT BEDTIME