BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 11626093 · Received April 7, 2021

    Report

    Report Number
    3005862821-2021-00009
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    February 24, 2021
    Report Date
    March 19, 2021
    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 · 1

    NO NONCONFORMANCE WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS (DOC#: (B)(4)) OF THE SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D200204-1). THE METER WAS SHIPPED TO (B)(4) ON (B)(6) 2019. RETURN METER (SERIAL#: (B)(4)) AND RETAINED ONE (SERIAL#: (B)(4)) WERE USED TO RE-EXAMINED THEIR SETTING AND ALL FUNCTIONS, AND NO MALFUNCTION OCCURRED. STANDBY CURRENT (8.5 UA) OF THE RETURN METER MET ACCEPTANCE CRITERIA (< 55 UA). STRIPS WERE MANUFACTURED ON 02-04-2020 AND WILL EXPIRE IN 02-2022. BECAUSE SUSPECTED STRIPS WERE NOT RETURNED TO OKB, RETAINED STRIPS (LOT#: D200204-1) WERE USED TO RE-TEST BY USING RETURN (SERIAL#: (B)(4)) AND RETAINED (SERIAL#: (B)(4)) METERS WITH ANY VALID CONTROL SOLUTIONS (BATCH# OF LEVEL LOW: 9AH1A99 AND EXP. BY 02-2022; BATCH# OF LEVEL HIGH: 0AH3A17 AND EXP. BY 12-2022), RESPECTIVELY. RE-TESTING RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 30~80 ; LEVEL HIGH: 200~310), AND DESICCANTS OF THE STRIP VIAL ARE STILL FUNCTIONAL (ORANGE COLOR). RETURN METER W/ RETAINED STRIPS: 49/50 (LEVEL LOW) AND 238/239 (LEVEL HIGH). RETAINED METER W/ RETAINED STRIPS: 48/52 (LEVEL LOW) AND 242/254 (LEVEL HIGH). 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 · 1

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2021 AROUND 11:00PM AT HOME. END-USER STATED THAT SHE TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A RESULT OF 50MG/DL. A NORMAL RESULT FOR HER FOR THAT TIME IF DAY IS USUALLY AROUND 159MG/DL. END-USER STATED THAT SHE CALLED HER DR OFFICE AND SHE WAS TOLD TO GO THE EMERGENCY ROOM. END-USER THEN STATED DROVE HERSELF TO (B)(6) LOCATED AT (B)(6). THE END-USER STATED THAT WHEN SHE ARRIVED AT THE HOSPITAL HER BLOOD GLUCOSE WAS TESTED, AND THEY RECEIVED A RESULT OF 179MG/DL. END-USER DOES NOT RECALL WHAT TREATMENT SHE RECEIVED AND WAS AT THE HOSPITAL FOR 1 HOUR. END-USER STATED THAT SHE WASN'T GIVEN ANY DISCHARGE INSTRUCTIONS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525542 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D200204-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization