BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10183045 · Received June 23, 2020

    Report

    Report Number
    3005862821-2020-00031
    Event Type
    Injury
    Date Received
    June 23, 2020
    Date of Event
    May 13, 2020
    Report Date
    May 27, 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 (B)(4) REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D161202-2). METER SETTING AND ALL FUNCTIONS OF THE SUSPECTED / RETURNED DEVICE WERE RE-TESTED, AND ALL OF THEM WERE OPERATED PROPERLY. STANDBY CURRENT OF THE DEVICE WAS RE-CHECKED AND THE CURRENT (1.0 UA) MET ACCEPTANCE CRITERIA (< 55 UA). STRIPS WERE MANUFACTURED ON 12/02/2016 AND WERE EXPIRED IN DEC. 2018. BECAUSE THE SUSPECTED STRIPS WERE EXPIRED AND OUT OF SPECIFICATIONS, THE SUSPECTED METER WAS TESTED BY USING ANY RETAINED STRIPS (LOT#: (D190819-1)) AND CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A95, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A15, EXP. BY DEC. 2020), AND RESULTS (LEVEL LOW: 48/47; LEVEL HIGH: 256/258) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85; LEVEL HIGH: 220~330). AS ABOVE, NO NON-CONFORMANCE AND MALFUNCTION OF THE SUSPECTED DEVICE WERE FOUND. BECAUSE PATIENT USED THE EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READING, SO THIS MATTER HAS TO BE CLOSED OUT WITH PATIENT'S OPERATION ISSUE.

    Description of Event or Problem · 1

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 2:50 AM AT HOME. END-USER STATED THAT SHE TESTED WITH HER PRODIGY METER AND RECEIVED A RESULT OF 500 MG/DL AROUND 3:00 AM. SHE STATED THAT SHE WAITED UNTIL THE MORNING TO DRIVE HERSELF TO THE HOSPITAL. SHE STATED THAT A NORMAL RESULT FOR HER FOR THAT TIME OF DAY IS USUALLY AROUND 90-100 MG/DL. THE END-USER STATED THAT SHE DROVE HERSELF TO THE HOSPITAL AT 7:00 AM. WHEN SHE ARRIVED AT (B)(6). SHE SAID THAT HER BLOOD GLUCOSE WAS 60 MG/DL. THE END-USER STATED THAT SHE IS NOT A DIABETIC AND ONLY USES HER PRODIGY GLUCOMETER WHEN SHE IS GIVEN STEROIDS FOR HER ASTHMA. THE END-USER STATED THAT SHE IS NOT PRESCRIBED INSULIN AND HAS ONLY BEEN GIVEN IT WHEN SHE HAS BEEN HOSPITALIZED. SHE WAS INFORMED THAT HER TEST STRIPS ARE EXPIRED. SHE STATED THAT SHE WAS AT THE HOSPITAL FOR 1 DAY AND WAS DISCHARGED. SHE DOES NOT RECALL WHAT HER BLOOD GLUCOSE WAS PRIOR TO BEING DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648005 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D161202-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization