BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10147206 · Received June 12, 2020

    Report

    Report Number
    3005862821-2020-00030
    Event Type
    Injury
    Date Received
    June 12, 2020
    Date of Event
    May 12, 2020
    Report Date
    May 26, 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#: D190729-1). RETAINED AND RETURN STRIPS (LOT#: D190729-1) WERE RE-TEST BY USING RETAINED (SERIAL#: (B)(4) METER WITH CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A95, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A15, EXP. BY DEC., 2020) BECAUSE THE SUSPECTED METER WAS NOT RETURNED, AND RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85; LEVEL HIGH: 220~330). RETAINED METER W/ RETURN STRIPS: 66/66 (LEVEL LOW) AND 263/277 (LEVEL HIGH). RETAINED METER W/ RETAINED STRIPS: 61/65 (LEVEL LOW) AND 269/276 (LEVEL HIGH) . AS ABOVE, NO NON-CONFORMANCE AND MALFUNCTION OF THE SUSPECTED STRIPS WERE FOUND. THE ROOT CAUSE OF THE COMPLAINT IS UNABLE TO BE VERIFIED WITHOUT THE SUSPECTED METER OR MORE USERS' INFORMATION. THEREFORE, THE COMPLAINT HAD TO BE CLOSED OUT IF NO FURTHER ACTION OR INFORMATION FROM THE USER.

    Description of Event or Problem · 1

    END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 4:00AM AT HOME. END-USER STATED THAT HIS METER IS GIVING HIM HIGH RESULTS WHEN TESTING WITH HIS PRODIGY METER. HE STATED THAT MEDICAL ATTENTION WAS SOUGHT DUE TO THE END-USER BEING INCOHERENT AND HE HAD A HIGH FEVER. END-USER STATED THAT HE TESTED HIS BLOOD GLUCOSE WITH HIS PRODIGY METER AND GOT A RESULT OF 114MG/DL. HE STATED THAT 2 MORE TESTS WERE PERFORMED WITH THE PRODIGY METER, BUT HE DOES NOT RECALL WHAT THE RESULT WERE. HE STATED THAT A NORMAL RESULT FOR HIM AROUND THAT TIME OF DAY IS USUALLY AROUND 205- 350MG/DL. HE STATED THAT PARAMEDICS WERE CALLED AROUND 3-5 MINUTES AFTER TESTING. THERE WAS NO FOOD OR MEDICATIONS CONSUMED WHILE WAITING FOR THE PARAMEDICS. THE END-USER STATED THAT THE PARAMEDICS ARRIVED WITHIN 5 MINS AND TESTED HIS BLOOD GLUCOSE WITH THEIR METER, BUT HE DOES NOT RECALL WHAT THE RESULT WAS. THE END-USER WAS TRANSPORTED TO (B)(6) LOCATED AT (B)(6). HE STATED THAT HE WAS GIVEN INSULIN (HE DOESN'T REMEMBER HOW MANY UNITS) AND WAS NOT ADMITTED BUT HE WAS AT THE HOSPITAL AROUND 4-5 HOURS HE STATED THAT WHEN HE WAS DISCHARGED HIS BLOOD GLUCOSE WAS CHECKED BUT HE DID NOT RECALL WHAT THE RESULT WAS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614052 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190729-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization