BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6204335 · Received December 27, 2016

    Report

    Report Number
    3005862821-2016-00121
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 23, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 RETURNED METER, THE STANDBY CURRENT TEST WAS 1.3UA. THE CRITERIA IS <55UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION WERE ALL OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETAIN STRIPS (SAME LOT AS PATIENT'S STRIP, LOT #D150825-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 67/69 MG/DL, FOR LEVEL HIGH WERE 251/259 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, WE CAN'T HAVE FURTHER INVESTIGATION ON HER STRIPS.

    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 PDC ON 08/22/2013. THE STRIP LOT #D150205-1 PROVIDED BY PATIENT WAS INCORRECT, IT SHOULD BE D150206-1. THE STRIP LOT #D150206-1 WAS MANUFACTURED ON 02/06/2015 AND EXPIRED IN 02/2017. OKB TESTED THE RETAIN STRIPS (STRIP LOT NUMBER:D150206-1) WITH CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 61/61 MG/DL; FOR LEVEL HIGH WERE 256/259 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 . OK BIOTECH RECEIVED NO OTHER COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. WE ARE UNABLE TO CONFIRM THE COMPLAINT BECAUSE DEVICE WAS NOT RETURNED AND NO FURTHER INFORMATION FROM CUSTOMER HAS BEEN RECEIVED, THIS MATTER HAS TO BE CLOSED OUT WITH UNDETERMINED ROOT CAUSE.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2016-00121 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM (B)(4) ON 12/27/2016 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Description of Event or Problem · 1

    THE END USER REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2016 BETWEEN 4:30 - 5:00 PM AFTER RECEIVING INCONSISTENT READINGS FROM THE PRODIGY DIABETES GLUCOSE METER. THE END USER WAS FEELING SLUGGISH, BLURRED VISION, INCOHERENT AND COULD NOT STAND UP. HER HUSBAND DROVE HER TO THE ER AND UPON ARRIVAL HER BLOOD GLUCOSE WAS 52 MG/DL. THE END USER STATED THAT INSULIN WAS ADMINISTERED AND SHE WAS ADMITTED TO THE HOSPITAL FOR 3 DAYS. NO FURTHER TREATMENT DETAILS WERE PROVIDED. UPON DISCHARGE HER BLOOD GLUCOSE WAS 164 MG/DL AND SHE WAS INSTRUCTED TO FOLLOW UP WITH HER PCP. AFTER HER FOLLOW UP VISIT WITH HER PCP SHE WAS ADVISED TO TAKE 20 UNITS OF LANTUS IN THE AM AND 6 UNITS OF HUMALOG AFTER MEALS. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856230 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D150825-1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R ACICLOVIR| ESTRATEST| GABAPENTIN| GEMFIBROZIL TWICE A DAY| HUMALOG| HYDROXYZINE (WATER PILL)| KLOR-CON (TWICE A DAY)| L-THYROXINE (THYROID)| LANTUS| PRILOSEC