BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 17496154 · Received August 10, 2023

    Report

    Report Number
    3005862821-2023-00010
    Event Type
    Injury
    Date Received
    August 10, 2023
    Date of Event
    June 29, 2023
    Report Date
    August 4, 2023
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO NONCONFORMANCE WAS FOUND AND RECORDED IN THE DOCUMENT ((B)(4)) AFTER OKB REVIEWED DEVICE HISTORY RECORD (DHF) OF THE SUSPECTED METER (SERIAL#: (B)(6) ) AND STRIPS (LOT#: D220922B-1). THE SUSPECTED METER THAT WAS SHIPPED TO PDC ON 2017-07-07 WAS USED TO RE-EXAMINE ITS SETTING AND ALL FUNCTIONS, AND NO MALFUNCTION OCCURRED. STANDBY CURRENT (1.2 UA) OF THE SUSPECTED ONE MET ACCEPTANCE CRITERIA (< 55 UA). SUSPECTED STRIPS WITH 2-YEAR SHELF LIFE WERE MANUFACTURED ON 2022-09-22 AND WILL EXPIRY IN SEP 2024. WE TESTED THE SUSPECTED STRIPS (LOT# D220922B-1) BY SUSPECTED METER WITH ANY VALID CONTROL SOLUTIONS WITH US (BATCH# OF LEVEL LOW: 2AH1A04 AND EXP. BY 2025-01-31; BATCH# OF LEVEL HIGH: 2AH3A19 AND EXP. BY 2025-01-31). GCS TEST RESULTS (LEVEL LOW: 74/73; LEVEL HIGH: 333/333) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 30~75; LEVEL HIGH: 220~340). AS ABOVE, NO NON-CONFORMANCE AND MALFUNCTION OF THE SUSPECTED ITEMS WERE FOUND. THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE VERIFIED WITHOUT MORE CRITICAL INFORMATION. THEREFORE, THE COMPLAINT HAS TO BE CLOSED OUT IF NO FURTHER ACTION AND INFORMATION FROM THE USER.

    Description of Event or Problem · 0

    CALLER STATED THAT HE SOUGHT MEDICAL ATTENTION ON (B)(6) 2023 AROUND 6:30-7:00PM AT HOME. CALLER STATED THAT THE END-USER CHECKED HIS BLOOD GLUCOSE WITH THE PRODIGY METER AND RECEIVED A RESULT OF 49MG/DL. A NORMAL RESULT FOR HIM FOR THAT TIME OF DAY IS USUALLY AROUND 150MG/DL. CALLER STATED THAT THE END-USER BECAME SHAKY NONVERBAL AND UNABLE TO STAY AWAKE AFTER TESTING SO SHE CALLED PARAMEDICS. THERE WAS NO FOOD DRINK OR MEDICATION CONSUMED WHILE WAITING FOR PARAMEDICS TO ARRIVE. PARAMEDICS ARRIVED WITHIN 10-15 MINUTES, TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER, AND RECEIVED A RESULT OF 37MG/DL. THE END-USER WAS TRANSPORTED TO (B)(6) HOSPITAL LOCATED AT (B)(6). CALLER STATED THAT WHEN HE ARRIVED AT THE HOSPITAL HIS BLOOD GLUCOSE WAS 37MG/DL. CALLER STATED THAT THE END-USER WAS GIVEN A GLUCOSE IV AND WAS ADMITTED TO THE HOSPITAL FOR TWO DAYS. CALLER STATED THAT THE END-USER WAS TOLD TO USE 30 UNITS OF LANTUS AND SLIDING SCALE (WAS NOT PROVIDED) CALLER STATED THAT WHEN HE WAS DISCHARGED HIS BLOOD GLUCOSE WAS 75MG/DL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2117139 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D220922B-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization LANTIS| NOVOLOG