BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10023127 · Received May 5, 2020

    Report

    Report Number
    3005862821-2020-00023
    Event Type
    Injury
    Date Received
    May 5, 2020
    Date of Event
    March 21, 2020
    Report Date
    April 6, 2020
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841503020
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO NON-CONFORMANCE WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED METER (SERIAL#: (B)(4) AND STRIPS (LOT#: D190509-1). THE METER WAS SHIPPED TO PDC ON (B)(6) 2018, AND STRIPS WERE MANUFACTURED ON 05/09/2019 AND WILL EXPIRE IN 05/2021. BECAUSE THE SUSPECTED BGMS WAS NOT RETURNED TO OKB, THE RETAINED METER (SERIAL#: (B)(4) WAS USED TO RE-TEST, AND THE COMPLAINT SITUATIONS DID NOT OCCUR. BESIDES, DESICCANTS OF RETAINED STRIPS (LOT#: D190509-1) FROM OKB'S WAREHOUSE WERE STILL FUNCTIONAL (ORANGE COLOR). STRIPS WERE USED TO RE-TEST WITH IN-HOUSE METER (SERIAL#: (B)(4) AND CONTROL SOLUTION (LEVEL LOW: BATCH# 8AH1A94, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A14, EXP. BY SEPT., 2020), AND RESULTS (LEVEL LOW: 52/55; LEVEL HIGH: 250/251) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85; LEVEL HIGH: 220~330). ACCORDING TO PDC'S SEPERATE COMPLIANT RECORD, PATIENT'S STRIPS HAD COLOR-CHANGED DESICCANTS, WHICH INDICATED SUSPECTED STRIPS BECAME DAMP, AND THOSE STRIPS CONTRIBUTED TO INACCURATE READINGS. THEREFORE, USER'S IMPROPER OPERATION AND PRESERVATION MOSTLY CAUSED THE MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 7:00PM AT HOME. END-USER STATED THAT SHE TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A RESULT OF 215MG/DL. A NORMAL RESULT FOR HER FOR THAT TIME OF DAY IS AROUND 120-156MG/DL. THE END-USER STATED THAT SHE TOOK HER INSULIN BASED OFF THAT RESULT. APPROXIMATELY 8 HOURS AFTER TESTING WITH HER PRODIGY METER THE END-USER STATED THAT SHE WAS FEELING LIGHT HEADED AND WAS SWEATING. PARAMEDICS WERE THEN CALLED. THE END-USER STATED THAT SHE DRANK 2 CUPS OF ORANGE JUICE WHILE WAITING FOR THE PARAMEDICS TO ARRIVE HOWEVER SHE DOES NOT RECALL HOW LONG IT TOOK THE TO ARRIVE. PARAMEDICS TESTED HER BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 120MG/DL. THE END-USER STATED SHE WAS NOT GIVEN ANY TREATMENT BY THE PARAMEDICS AND WAS NOT TRANSPORTED TO THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487739 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. D190509-1 00384841503020

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR