BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 12340905 · Received August 19, 2021

    Report

    Report Number
    3005862821-2021-00015
    Event Type
    Injury
    Date Received
    August 19, 2021
    Date of Event
    July 22, 2021
    Report Date
    July 29, 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
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO NONCONFORMANCE WAS FOUND AND RECORDED IN THE DOCUMENT (QA-W-21-03) AFTER OKB REVIEWED DEVICE HISTORY RECORD (DHF) OF THE SUSPECTED METER (SERIAL#: (B)(4)) AND STRIPS (LOT#: D200617-1). THE METER WAS SHIPPED TO PDC ON 10-30-2020. STRIPS WERE MANUFACTURED ON 06-17-2020 AND WILL EXPIRE IN 06-2022. BECAUSE THE SUSPECTED ITEMS WAS NOT RETURNED TO OKB, THE RETAINED METER (SERIAL#: (B)(4)) WAS USED TO RE-EXAMINED ITS SETTING AND ALL FUNCTIONS, AND NO MALFUNCTION OCCURRED. ALSO, RETAINED STRIPS OF SAME BATCH AS SUSPECTED STRIPS WERE RE-TEST BY THE RETAINED METER AND ANY VALID CONTROL SOLUTIONS (BATCH# OF LEVEL LOW: 9AH1A99 AND EXP. BY 02-2022; BATCH# OF LEVEL HIGH: 0AH3A17 AND EXP. BY 12-2022). THE RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85 ; LEVEL HIGH: 210~320), AND DESICCANTS OF THE STRIP VIAL ARE STILL FUNCTIONAL (ORANGE COLOR). 1 RETAINED METER W/ RETAINED STRIPS: 60/63 (LEVEL LOW) AND 289/295 (LEVEL HIGH) 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 · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2021 AROUND 12:00PM AT HOME. CALLER STATED THAT THE END-USER TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A RESULT OF 360MG/DL. A NORMAL RESULT FOR THAT TIME OF DAY USUALLY AROUND 100MG/DL. CALLER STATED THAT THE END-USER TOOK HER INSULIN BASED ON THE RESULT SHE RECEIVED. END-USER IS NOT ON A SLIDING SCALE. THE END-USER TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A RESULT OF 73MG/DL CALLER STATED THAT HE FOUND THE END-USER UNCONSCIOUS AROUND 10-15 MINUTES LATER SO HE CALLED PARAMEDICS. THERE WAS NO FOOD DRINK OR MEDICATION CONSUMED WHILE WAITING FOR THE PARAMEDICS. PARAMEDICS ARRIVED WITHIN 10-15 MINUTES AND TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 38MG/DL. PARAMEDICS GAVE THE END-USER GLUCOSE BY IV AND TRANSPORTED HER TO (B)(6) HOSPITAL . CALLER DID NOT RECALL WHAT THE END-USERS BLOOD GLUCOSE WAS UPON ARRIVING AT THE HOSPITAL. THE HOSPITAL CONTINUED TO ADMINISTER GLUCOSE BY IV AND THE END-USER STAYED THERE OVERNIGHT. CALLER DOES NOT RECALL WHAT HER DISCHARGE INSTRUCTIONS WERE OR WHAT HER BLOOD GLUCOSE WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239306 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D200617-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization ATORVASTATIN 80MG| BRIMONIDINE TART 5MG| BUMETANIDE 1MG| BUMETANIDE1MG| CARVEDILOL 12.5MG| DORZOLAMIDE 10MG| DOXAZOSIN MESYLATE 4MG| EZETIMIBE 10MG| GABAPENTIN 400MG| HUMALOG 10MG| LANTUS 100MG| LATANOPROST 2.5MG| PANTOPRAZOLE SOD| SERTRALINE 50MG