BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6192210 · Received December 20, 2016

    Report

    Report Number
    3005862821-2016-00114
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 14, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    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 04/28/2011. ACCORDING TO REPORTER'S DESCRIBE,THE SUSPECTED STRIP LOT #52800-D140211-1, WHICH WAS MANUFACTURED ON 02/11/2014 AND EXPIRED ON 02/11/2016. 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 4:00PM AFTER THE END USER WAS RECEIVING ERRONEOUS READINGS FROM THE PRODIGY GLUCOSE METER. THE END USER WAS FEELING CLAMMY, DIAPHORETIC AND SWEATING PROFUSELY AND THE PARAMEDICS WERE CALLED. THE READING ON THE PRODIGY METER AT THE TIME OF THE EVENT WAS 144 MG/DL. THE PARAMEDICS PERFORMED A TEST WITH THEIR METER AND RECEIVED A RESULT OF 40 MG/DL AND ADMINISTERED AN IV OF GLUCOSE TO ASSIST IN RAISING THE BLOOD GLUCOSE LEVEL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840368 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51900 52800 - D140211-1

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention ASPART (INSULIN)| ATENOLO| CAPSAICIN (FOR JOINT PAIN)| CLOPIDOGREL| CYCLOSPORINE (EYE DROPS)| DOCUSATE| DORZOLAMIDE (EYE DROPS)| FINASTERIDE| FUROSEMIDE| GABAPENTIN| GLARGINE (INSULIN)| GLUCOSE TABLETS (4 PER DAY)| GUAIFENESIN| IPRATROPIUM (NASAL SPRAY)| LACTULOSE (EYE DROP)| LATANOPROST| LEVOTHYROXINE| LIDOCAINE CREAM (NERVE PAIN)| MAGNESIUM OXIDE| METFORMIN| METHOCARBAMOL| MIRALAX| OMEPRAZOLE| SIMVASTATIN| TAMSULOSIN| TRAZODONE| TYLENOL| UREA CREAM FOR DRY SKIN| VITAMIN B12 SHOTS| VITAMIN D3