BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 6123852 · Received November 23, 2016

    Report

    Report Number
    3005862821-2016-00103
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 08/22/2013. 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

    END USER'S HUSBAND REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2016 AT 5;30 PM. THE END USER DISPLAYED SIGNS OF BEING LETHARGIC AND INCOHERENT. A BLOOD GLUCOSE TEST COULD NOT BE PERFORMED ON THE PRODIGY DIABETES METER DUE TO CONTINOUS ERROR MESSAGES. THE END USER VISITED THE ER AND UPON ARRIVAL HER BLOOD GLUCOSE WAS 132 MG/DL AND NO TREATMENT WAS ADMINISTERED. LABORATORY TESTING WAS PERFORMED BUT NO FURTHER DETAILS WERE PROVIDED. PRIOR TO DISCHARGE FROM THE ER THE END USER'S BLOOD GLUCOSE WAS 105MG/DL AND SHE WAS INSTRUCTED TO FOLLOW-UP WITH HER PCP. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776194 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 72500 - D6160225-1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention CARVEDILOL 3.125MG 1 TABLET TWICE DAILY| GABAPENTIN 100MG 1 TABLET TWICE DAILY| LIOTHYRONINE 25MCG 1 TAB DAILY| METOLAZONE 5MG 1 TAB 3 TIMES BEFORE MEALS| NOVOLOG INSULIN| RENVELA 800 MG 2 TAB AT MEALS 3TIMES A DAY