BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9966386 · Received April 16, 2020

    Report

    Report Number
    3005862821-2020-00021
    Event Type
    Injury
    Date Received
    April 16, 2020
    Date of Event
    March 16, 2020
    Report Date
    March 30, 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#: D190502-3). PATIENT DID NOT RETURN HIS METER, SO WE TESTED THE RETAINED AND RETURN STRIPS (LOT#: D190502-3) WITH OUR IN-HOUSE METER (SERIAL#: (B)(4)) AND CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A94, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A14, EXP. BY SEPT., 2020), AND RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85; LEVEL HIGH: 210~320). ONLY 2 REMAINING STRIPS HAD BEEN RETURNED FROM PATIENT. RETAINED METER W/ RETURN STRIPS: 70 (LEVEL LOW) AND 291 (LEVEL HIGH). RETAINED METER W/ RETAIN STRIPS: 65/63 (LEVEL LOW) AND 281/256 (LEVEL HIGH). AS ABOVE, NO NON-CONFORMANCE OF THE SUSPECTED STRIPS WERE FOUND. WE ARE UNABLE TO CONFIRM THE COMPLAINT BECAUSE DEVICE WAS NOT RETURNED AND NO FURTHER INFORMATION FROM CUSTOMER HAS BEEN RECEIVED, THIS MATTER HAS TO BE CLOSED OUT WITH UNDETERMINED ROOT CAUSE.

    Description of Event or Problem · 1

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 6:00PM AT THE NURSING HOME. END-USER STATED THAT HE GOT A RESULT OF HI ON HIS PRODIGY METER, HE TESTED AGAIN AND RECEIVED THE SAME RESULT. THE END-USER STATED THAT A NORMAL RESULT FOR THAT TIME OF DAY IS AROUND 102-200MG/DL. THE END-USER STATED THAT HE WENT TO THE NURSES STATION ABOUT 15 MINUTES LATER AND THEY CALLED EMS. WHILE WAITING FOR THE EMS TO ARRIVE THE END-USER HAD ORANGE JUICE AND GLUCOSE BY MOUTH. EMS ARRIVED WITHIN 10 MINUTES, HE STATED THAT THE EMS TESTED HIS BLOOD GLUCOSE, BUT HE DOESN'T KNOW WHAT THE RESULT WAS. EMS STARTED AND IV AND ADMINISTERED A GLUCOSE SOLUTION. THE END-USER WAS TRANSPORTED TO (B)(6) - EMERGENCY ROOM LOCATED AT (B)(6). END-USER STATED THAT HE DOES NOT RECALL WHAT TREATMENT HE RECEIVED OR WHAT HIS BLOOD GLUCOSE WAS WHEN HE ARRIVED OR WHEN HE WAS DISCHARGED. HE WAS TOLD TO FOLLOW UP WITH HIS PRIMARY CARE DOCTOR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431479 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190502-3 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization