BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 17432025 · Received August 1, 2023

    Report

    Report Number
    3005862821-2023-00009
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    July 7, 2023
    Report Date
    July 27, 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
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CASE WITH REFERENCE TO IMPORTE'S MDR#3008789114-2023-00008 WAS RECEIVED ON JULY 27, 2023 AND ITS INITIAL INVESTIGATION WAS COMPLETED ON AUGUST 01,2023. THE ROOT CAUSE WAS USER'S IMPROPER OPERATION WITH EXPIRED STRIPS(LOT#D130802-1). THE FINDING OF THE INVESTIGATION ARE IN BELOW: THE SUSPECTED METER ((B)(6) SHIPPED TO PDC ON 2011-11-29, AND WAS MADE MORE THAN 10 YEARS BEFORE. ITS DEVICE HISTORY RECORD (DHF) WERE NOT PRESERVED BASED ON OKB'S DOCUMENT CONTROL POLICY COMPLIANCE WITH CFR 820.180 (B). THE SUSPECTED METER RETURNED BY PATIENT WAS RE-EXAMINE THE SETTING AND ALL FUNCTIONS, AND NO MALFUNCTION OCCURRED. STANDBY CURRENT (32.4UA) MET ACCEPTANCE CRITERIA (< 55 UA). THE STRIP LOT NUMBER USED BY PATIENT WAS MANUFACTURED ON 2013-08-02 AND EXPRIED FOR MORE THAN 8 YEARS. AND EXPIRED STRIPS MAY CAUSE INACCURATE BLOOD GLUCOSE READINGS. WARNING INFORMATION REGARDING NOT TO USE EXPIRED STRIPS WAS DISCLOSED IN USER'S MANUAL AND STRIP LABELING TO AVOID THIS PROBLEM. FURTHERMORE, THE EXPIRATION DATE WAS SHOWN CLEARLY ON THE STRIP LABEL, STRIP BOX AND KIT BOX. THEREFORE, THE ROOT CAUSE OF THE COMPLAINT RESULTED FROM USER'S IMPROPER OPERATION.

    Additional Manufacturer Narrative · 0

    THE METER WAS SHIPPED TO PDC ON (B)(6) 2011. BECAUSE THE SUSPECTED DEVICE WAS NOT RETURNED TO OKB, AND IT WAS MADE OVER 10 YEARS AGO. ITS DEVICE HISTORY RECORD (DHF) WERE NOT PRESERVED BASED ON OKB'S DOCUMENT CONTROL POLICY COMPLIANCE WITH CFR 820.180 (B). NO SIMILAR MATTER WAS FOUND AFTER OKB REVIEWED ALL COMPLAINT RECORDS THAT WERE THE SAME BATCH AS THE METER. NO NONCONFORMANCE WAS FOUND AND RECORDED IN THE DOCUMENT (QA-W-21-03) AFTER OKB REVIEWED DEVICE HISTORY RECORD (DHF) OF SUSPECTED STRIPS (LOT#: D130802-1). STRIPS WERE EXPIRED AND OUT OF SPECIFICATIONS, AND THEY MAY CAUSE INACCURATE BLOOD GLUCOSE READINGS. WARNING INFORMATION REGARDING NOT TO USE EXPIRED STRIPS WAS DISCLOSED IN USER'S MANUAL AND STRIP LABELING TO AVOID THIS PROBLEM. FURTHERMORE, THE EXPIRATION DATE WAS SHOWN CLEARLY ON THE STRIP LABEL, STRIP BOX AND KIT BOX. THEREFORE, THE ROOT CAUSE OF THE COMPLAINT RESULTED FROM USER'S IMPROPER OPERATION. THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE VERIFIED WITHOUT THE SUSPECTED ITEMS AND MORE CRITICAL INFORMATION. THEREFORE, THE COMPLAINT HAS TO BE CLOSED OUT IF NO FURTHER ACTION OR INFORMATION FROM THE USER.

    Description of Event or Problem · 0

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT#3005862821-2023-00009 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICE. DEVICE WAS RETURNED FROM PRODIGY DIABETES CARE ON AUGUST 21, 2023 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICE WAS COMPLETED BY OK BIOTECH.

    Description of Event or Problem · 0

    CALLER STATED THAT HE SOUGHT MEDICAL ATTENTION ON (B)(6) 2023 AROUND 10:30AM AT HOME. CALLER STATED THAT HE TESTED HIS BLOOD GLUCOSE WITH HIS PRODIGY METER AND RECEIVED A RESULT OF 290MG/DL. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 110MG/DL. CALLER STATED THAT HE PERFORMED ANOTHER TEST AND RECEIVED A RESULT OF 224MG/DL. CALLER STATED THAT HE THEN DROVE HIMSELF TO (B)(6) HOSPITAL EMERGENCY ROOM LOCATED AT (B)(6). DUE TO GETTING HIGH RESULTS. CALLER STATED THAT HE DID NOT CONSUME ANY MEDICATION OR FOOD AND DRINK PRIOR TO GOING TO THE HOSPITAL. CALLER STATED THAT WHEN HE ARRIVED AT THE HOSPITAL HIS BLOOD GLUCOSE WAS 104MG/DL. CALLER STATED THAT HE WAS NOT GIVEN ANY TREATMENT FOR HIS BLOOD GLUCOSE AND HE WAS DISCHARGED WITH INSTRUCTIONS TO TAKE HIS MEDICATIONS. CALLER WAS USING TEST STRIPS THAT WERE EXPIRED, HE WAS EDUCATED NOT TO USE EXPIRED PRODUCTS AND TO DISCARD THEM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335837 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D130802-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male ASPIRIN| BIKTARVY| HYDRO-MORPHINE| METOPROLOL| OMEPRAZOLE| PRAVASTATIN