BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9942176 · Received April 9, 2020

    Report

    Report Number
    3005862821-2020-00015
    Event Type
    Injury
    Date Received
    April 9, 2020
    Date of Event
    February 21, 2020
    Report Date
    March 10, 2020
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO NON-CONFORMITY WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D160804-1). THE METER WAS SHIPPED TO PDC ON 06/17/2019. STRIPS WERE MANUFACTURED ON 08/04/2016 AND WERE EXPIRED IN 08/2018. BECAUSE THE SUSPECTED BGMS WAS NOT RETURNED TO OKB, THE RETAINED DEVICE (SERIAL#: (B)(4)) WAS USED TO RE-TEST, AND THE COMPLAINT SITUATIONS DID NOT OCCUR. ALSO, THE SUSPECTED STRIPS WERE EXPIRED AND OUT OF SPECIFICATIONS. THE ROOT CAUSE OF THE ISSUE IS UNABLE TO BE VERIFIED WITH EXPIRED STRIPS AND INSUFFICIENT USER'S INFORMATION. THE COMPLAINT HAS TO BE CLOSED OUT IF NO FURTHER ACTION OR INFORMATION FROM THE USER.

    Description of Event or Problem · 1

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 1:45PM AT HOME. END-USER STATED THAT HE TESTED HIS BLOOD GLUCOSE WITH HIS PRODIGY METER AND RECEIVED A RESULT OF HI. A NORMAL RESULT FOR HIM FOR THAT TIME OF DAY IS AROUND 157MG/DL. HE THEN TESTED 4 MORE TIMES AND RECEIVED A RESULT OF HI AGAIN. THERE WAS NO FOOD OR MEDICATION CONSUMED PRIOR TO GOING TO THE HOSPITAL. THE END-USER STATED THAT HE STARTED TO FEEL DIZZY AND HAD A HEADACHE, SO HE WENT TO (B)(6). UPON ARRIVING HIS BLOOD GLUCOSE WAS 72MG/DL. HIS VITALS WERE CHECKED, AND HE DID NOT RECEIVE ANY TREATMENT FOR HIS BLOOD GLUCOSE. HE WAS TOLD BY THE HOSPITAL STAFF TO ENSURE HE EATS. END-USER WAS EDUCATED TO NOT USE EXPIRED PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409905 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D160804-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization