BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 12097906 · Received July 1, 2021

    Report

    Report Number
    3005862821-2021-00012
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    June 5, 2021
    Report Date
    June 15, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO NONCONFORMANCE WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS ((B)(4)) OF THE SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D150923-1). THE METER WAS SHIPPED TO PDC ON (B)(6) 2019. STRIPS WERE MANUFACTURED ON 09-23-2015 AND EXPIRED IN 09-2017. BECAUSE THE SUSPECTED ITEMS WERE NOT RETURNED TO OKB, THE RETAINED METER (SERIAL#: (B)(4)) WAS USED TO RE-EXAMINE ITS SETTING AND ALL FUNCTIONS, AND NO MALFUNCTION OCCURRED. ALSO, STRIPS WERE EXPIRED AND OUT OF SPECIFICATIONS. THE RETAINED METER WAS RE-TESTED BY ANY RETAINED STRIPS (LOT#: D191017-1) FROM OKB'S WAREHOUSE AND ANY VALID CONTROL SOLUTIONS (BATCH# OF LEVEL LOW: 9AH1A02 AND EXP. BY 02-2022; BATCH# OF LEVEL HIGH: 0AH3A17 AND EXP. BY 12-2022). RE-TESTING RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85 ; LEVEL HIGH: 210~320), AND DESICCANTS OF THE STRIP VIAL ARE FUNCTIONAL (ORANGE COLOR). 2.1 RETAINED METER W/ RETAINED STRIPS: 58/64 (LEVEL LOW) AND 298/309 (LEVEL HIGH) . ALTHOUGH THE RETAINED METER OPERATED PROPERLY, 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.

    Description of Event or Problem · 1

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2021 IN THE MORNING AT HOME. END-USER STATED THAT SHE TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A RESULT OF 40MG/DL. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY UNDER 100 MG/DL. SHE STATED THAT NOT LONG AFTER TESTING SHE WAS FOUND UNRESPONSIVE. THE END-USER STATED THAT PARAMEDICS WERE CALLED IMMEDIATELY AFTER TESTING. CALLER STATED THAT SHE HAS A SLIDING SCALE FOR HER INSULIN HOWEVER SHE DECLINED TO PROVIDE THE SLIDING SCALE INFORMATION. END-USER WAS USING EXPIRED TEST STRIPS. THERE WAS NO FOOD DRINK OR MEDICATION CONSUMED WHILE WAITING FOR PARAMEDICS TO ARRIVE. WHEN PARAMEDICS ARRIVED THEY ADMINISTERED A GLUCOSE IV. THE END-USER DOES NOT RECALL HOW LONG IT TOOK PARAMEDICS TO ARRIVE, HOWEVER SHE WAS TRANSPORTED TO (B)(6). SHE DOES NOT RECALL WHAT HER BLOOD GLUCOSE WAS WHEN SHE ARRIVED AT THE HOSPITAL, SHE STATED THAT SHE WAS ADMITTED TO THE HOSPITAL FOR 4 DAYS. THE END-USER DOES NOT RECALL WHAT OTHER TREATMENT WAS RECEIVED NOR DOES SHE REMEMBER WHAT HER BLOOD GLUCOSE WAS WHEN SHE WAS DISCHARGED. END-USER STATED THAT WHEN SHE WAS DISCHARGED SHE WAS TOLD TO TEST HER BLOOD GLUCOSE EVERY DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999342 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D150923-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization