BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10342697 · Received July 30, 2020

    Report

    Report Number
    3005862821-2020-00042
    Event Type
    Injury
    Date Received
    July 30, 2020
    Date of Event
    June 28, 2020
    Report Date
    July 13, 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-CONFORMANCE WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED DEVICE (METER SERIAL#: (B)(4) AND STRIP LOT#: D181031-1). RETURN AND RETAINED STRIPS (LOT#: D181031-1) WERE RE-TESTED BY USING RETURN (SERIAL#: (B)(4)) AND RETAINED (SERIAL#: (B)(4)) METERS WITH CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A95, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A15, EXP. BY DEC., 2020), RESPECTIVELY, AND RESULTS WERE SHOWN BELOW. ONLY 2 REMAINING STRIPS HAD BEEN RETURNED FROM THE CLIENT. 2.1 RETURN METER W/ RETURN STRIPS: 70 (LEVEL LOW) AND 381 (LEVEL HIGH), 2.2 RETURN METER W/ RETAINED STRIPS: 80/79 (LEVEL LOW) AND 279/283 (LEVEL HIGH), 2.3 RETAINED METER W/ RETAINED STRIPS: 79/81 (LEVEL LOW) AND 280/274 (LEVEL HIGH), 3. DESICCANTS OF RETAINED STRIPS FROM OKB'S WAREHOUSE WERE STILL FUNCTIONAL (ORANGE COLOR), AND TESTING RESULTS ABOVE MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85; LEVEL HIGH: 210 ~320). HOWEVER, DESICCANTS OF RETURN STRIPS FROM THE CLIENT WERE INEFFECTIVE (GREEN COLOR), AND TESTING RESULTS ABOVE WERE FAILED. ABNORMAL HIGH RESULTS WERE OBTAINED BECAUSE STRIPS HAVE GOT DAMP. WARNING INFORMATION REGARDING CLOSE THE VIAL LID OF STRIPS IMMEDIATELY WAS DISCLOSED IN USER'S MANUAL, STRIP BOX AND LABELING, VIAL LABEL AND OUTSIDE SURFACE OF THE LID OF STRIP BOTTLE. 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 3:00PM AT HOME. END-USER STATED THAT SHE TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A RESULT OF 297MG/DL. SHE STATED THAT SHE THEN TOOK HER INSULIN BASED OFF THAT RESULT. THE END-USER STATED THAT HER HUSBAND FOUND HER UNCONSCIOUS IN HER DINING ROOM. THE END-USER STATED THAT HER HUSBAND TESTED HER BLOOD GLUCOSE WITH HIS METER AND RECEIVED A RESULT OF 37MG/DL. SHE STATED THAT HER HUSBAND CALLED PARAMEDICS. SHE DOESN'T KNOW HOW LONG IT TOOK FOR PARAMEDICS TO ARRIVE AND SHE DOES NOT RECALL IF ANY MEDICATION WAS GIVEN WHILE WAITING FOR PARAMEDICS. WHEN PARAMEDICS ARRIVED, THEY GAVE HER GLUCAGON AND TRANSPORTED HER TO (B)(6). SHE DOES NOT KNOW WHAT HER BLOOD GLUCOSE WAS WHEN SHE GOT TO THE HOSPITAL. END-USER DOES NOT KNOW WHAT TESTS WERE PERFORMED AT THE HOSPITAL ONLY THAT BLOOD WAS DRAWN. SHE STATED THAT SHE WAS AT THE HOSPITAL FOR 8 HOURS AND WAS DISCHARGED WITH A BLOOD GLUCOSE THAT WAS AROUND 160-170MG/DL NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809080 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D181031-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization