BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9619760 · Received January 23, 2020

    Report

    Report Number
    3005862821-2020-00005
    Event Type
    Injury
    Date Received
    January 23, 2020
    Date of Event
    December 5, 2019
    Report Date
    January 9, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL MANUFACTURING RECORDS OF THE SUSPECTED DEVICE (METER SERIAL#: (B)(4)) WERE REVIEWED, AND NO NON-CONFORMANCE WAS FOUND. METER SETTING AND ALL FUNCTIONS OF THE SUSPECTED DEVICE WERE RE-TESTED, AND ALL OF THEM WERE OPERATED PROPERLY. STANDBY CURRENT AND PERFORMANCE OF THE DEVICE WERE RE-CHECKED. THE CURRENT (3.8 UA) MET ACCEPTANCE CRITERIA (< 55 UA) AND PERFORMANCE TESTING WAS QUALIFIED BY USING ELECTRONIC STRIPS (100 K AND 200 K). AS ABOVE, NO NON-CONFORMANCE AND MALFUNCTION OF THE SUSPECTED DEVICE WERE FOUND. THE SUSPECTED DEVICE WAS RE-TESTED BY USING RETAINED STRIPS (LOT#: D190219-1) AND CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A94, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A14, EXP. BY SEPT., 2020), AND RESULTS (LEVEL LOW: 61/59; LEVEL HIGH: 253/249) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85; LEVEL HIGH: 210~320). AS ABOVE, NO NON-CONFORMANCE AND MALFUNCTION OF THE SUSPECTED DEVICE WERE FOUND. HOWEVER, THE PROBLEM MIGHT BE CAUSED BY STRIPS OR THE OTHERS. THE ROOT CAUSE OF THE COMPLAINT IS UNABLE TO BE VERIFIED WITHOUT ITS STRIPS AND LACK OF MORE USERS' INFORMATION. THE MATTER HAS TO BE CLOSED OUT IF NO FURTHER ACTION FROM THE CUSTOMER.

    Description of Event or Problem · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 5 OR 6PM AT HOME. CALLER STATED THAT SHE TESTED THE END-USERS BLOOD GLUCOSE AND RECEIVED (DID NOT SPECIFY RESULT), SO SHE THEN GAVE HIM INSULIN BASED OFF THAT RESULT. THE END-USER HAS THE FOLLOWING SLIDING SCALE FOR HIS INSULIN: 101-150MG/DL 6 UNITS 151-200MG/DL 8 UNITS 201- 250MG/DL 10 UNITS 251-300MG/DL 12 UNITS. CALLER SAID SHE CALLED PARAMEDICS WHEN SHE WENT HOME ABOUT 4 HOURS LATER. THE CALLER STATED THE END- WAS UNABLE TO SPEAK AND WAS VERY LETHARGIC AND HIS BLOOD GLUCOSE WAS 61MG/DL. PARAMEDICS ARRIVED WITHIN 10 MINUTES AND TESTED THE END-USER WITH THEIR GLUCOMETER AND RECEIVED A RESULT OF 51MG/DL. CALLER STATED THAT THE END-USER WAS GIVEN AN IV SOLUTION, BUT SHE IS UNAWARE OF WHAT WAS IN AND HE WAS TRANSFERRED TO THE HOSPITAL. THE CALLER DOES NOT KNOW WHAT THE END-USERS BLOOD GLUCOSE WAS UPON ARRIVING AT THE HOSPITAL. CALLER REFUSED ANY FURTHER INFORMATION. SHE STATED THAT THE END-USER WAS TREATED AT (B)(6). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83207 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization