BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9966385 · Received April 16, 2020

    Report

    Report Number
    3005862821-2020-00020
    Event Type
    Injury
    Date Received
    April 16, 2020
    Date of Event
    March 11, 2020
    Report Date
    March 29, 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#: D181031-2). RETURN AND RETAINED STRIPS (LOT#: D181031-2) WERE RE-TESTED BY USING RETURN METER (SERIAL#: (B)(4)) AND RETAINED METER (SERIAL#: (B)(4)) WITH CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A94, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A14, EXP. BY SEPT., 2020), RESPECTIVELY, AND RESULTS WERE SHOWN BELOW. *ONLY 2 REMAINING STRIPS HAD BEEN RETURNED FROM THE PATIENT. RETURN METER W/ *RETURN STRIPS: 134** (LEVEL LOW) AND 338** (LEVEL HIGH). RETURN METER W/ RETAINED STRIPS: 73/72 (LEVEL LOW) AND 285/258 (LEVEL HIGH). RETAINED METER W/ RETAINED STRIPS: 74/75 (LEVEL LOW) AND 291/279 (LEVEL HIGH). 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 PATIENT 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 2:30PM AT HOME. END-USER STATED THAT HIS METER IS GIVING HIM HIGHER THAN NORMAL RESULTS. HE SAID HE TESTED BEFORE BREAKFAST GOT A RESULT OF 320MG/DL , A NORMAL RESULT FOR THAT TIME OF DAY IS AROUND 95-130MG/DL. HE SAID THAT HE TOOK HIS DAILY MEDICATIONS AND HAD A BREAKFAST OF 2 WAFFLES COFFEE, BANANA NUT BREAD. HE STATED THAT HIS GIRLFRIEND FOUND HIM INCOHERENT ABOUT 5 HOURS AFTER TESTING AND CALLED EMS. END-USER DOES NOT RECALL HOW LONG IT TOOK EMS TO ARRIVE ONLY THAT THEY CHECKED HIS METER ( UNCLEAR AS TO HOW THIS WAS DONE ). THE END-USER STATED THAT THE EMS DID NOT TEST HIM WITH THEIR METER. THE END-USER STATED THAT EMS ATTEMPTED TO START AN IV BUT WERE UNABLE DUE TO HIM THRASHING AROUND. UPON ARRIVING AT THE HOSPITAL, THE END-USER STATED THAT HIS BLOOD GLUCOSE WAS 46MG/DL. HE WAS GIVEN IV FLUID AND A GLUCOSE TO RAISE HIS BLOOD GLUCOSE. HE STATED THAT HE WAS ADMITTED TO THE HOSPITAL FOR 3 DAYS. THE END-USER STATED HE WAS TOLD THAT HIS METER IS READING 1000 POINT HIGHER THAT THE HOSPITALS METER. THE END-USER ALSO STATED THAT HE WASN'T GIVEN ANY OTHER TREATMENT. HE SAID WHEN HE WAS DISCHARGED FROM THE HOSPITAL HIS BLOOD GLUCOSE WAS 190MG/DL. HE WAS TOLD TO FOLLOW UP WITH HIS PRIMARY DOCTOR IN WEEK. AFTER SEEKING MEDICAL ATTENTION HIS NOVOLOG MIX FLEX PEN WAS CHANGED FROM 75-25 TO 70/30. HE WAS TREATED AT (B)(6). NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431481 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D181031-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization