BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 16020747 · Received December 21, 2022

    Report

    Report Number
    3005862821-2022-00014
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    November 26, 2022
    Report Date
    December 16, 2022
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    1. NO NONCONFORMANCE WAS FOUND IN THE DOCUMENT (QA-W-21-03) AFTER OKB REVIEWED DEVICE HISTORY RECORD (DHF) OF THE SUSPECTED METER (SERIAL#: (B)(4) AND STRIPS (LOT#: D210127-1).2. THE SUSPECTED METER SHIPPED TO PDC ON 2015-10-30 AND RETURNED TO OKB ON DEC. 19, 2022. WE TESTED THE RETURNED METER ON ALL SETTING AND FUNCTIONS, AND NO MALFUNCTION WAS FOUND. STANDBY CURRENT OF THE RETURNED METER (0.9 UA) MET ACCEPTANCE CRITERIA (< 55 UA).3. BECAUSE PATIENT DID NOT RETURN HER STRIPS, THE BATCH STRIPS (LOT#D210127-1) WERE MANUFACTURED ON 2021-01-27 AND WILL EXPIRY IN JAN 2023. WE TESTED THE RETAINED STRIPS (LOT#D210127-1) BY RETURNED METER WITH ANY VALID CONTROL SOLUTIONS WITH US (BATCH# OF GCS LEVEL LOW: 0AH1A03 AND EXP. BY 2022-12-31; BATCH # OF GCS LEVEL HIGH: 0AH3A17 AND EXP. BY 2022-12-31). GCS TEST RESULTS (LEVEL LOW: 54/54; LEVEL HIGH: 254/254) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 30~80; LEVEL HIGH: 220~330). 4.AS ABOVE, NO NON-CONFORMANCE OR MALFUCTION ON THE RETRUNED METER. THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE VERIFIED IF PATIENT DOSE NOT SENDING BACK THE SUSPECTED STRIPS TO US AND NO MORE CRITICAL INFORMATION. THEREFORE, THE COMPLAINT HAS TO BE CLOSED OUT IF NO FURTHER ACTION OR INFORMATION FROM THE USER.

    Description of Event or Problem · 0

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2022 AROUND 8:30PM AT HOME. CALLER STATED THAT SHE PERFORMED A BLOOD GLUCOSE TEST WITH HER PRODIGY METER AND RECEIVED A RESULT OF 150MG/DL. A NORMAL RESULT FOR THAT TIME OF DAY IS USUALLY AROUND 113MG/DL. CALLER STATED THAT SHE TESTS HER BLOOD GLUCOSE 4 TIMES A DAY. CALLER STATED THAT SHE TOOK HER MEDICATION AS PRESCRIBED SEE ALL THAT ARE LISTED. CALLER STATED THAT SHE STARTED TO FEEL CONFUSED AND DAZE AND HAD SOMEONE TAKE HER TO (B)(6) HOSPITAL LOCATED AT (B)(6). CALLER STATED THAT WHEN SHE ARRIVED AT THE HOSPITAL HER BLOOD GLUCOSE WAS 43MG/DL. SHE DOES NOT RECALL HOW MUCH TIME PASSED BETWEEN TESTING WITH THE PRODIGY METER AND HER GOING TO THE HOSPITAL. CALLER STATED THAT SHE WAS AT THE HOSPITAL FOR 5-6 HOURS. CALLER STATED THAT HER VITALS WERE CHECKED ALONG WITH TESTING FOR A UTI. CALLER STATED THAT NO CHANGES WERE MADE TO HER DIABETIC MEDICATION BEFORE OR AFTER SEEKING MEDICAL ATTENTION. CALLER STATED THAT SHE DOES NOT RECALL WHAT HER BLOOD GLUCOSE WAS PRIOR TO BEING DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1981603 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D210127-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female ASPIRIN| ATORVASTATIN| FENOFIBRATE| HUMALOG| JARDIANCE| LANTUS| LASIX| LOPRESSOR| MAGNESIUM| METAMUCIL| METFORMIN| METOLAZONE| PREVAGEN| PROTOCHLORIDE| SENOKOT| VITAMIN B| VITAMIN C| VITAMIN D13| WARFARIN| ZINC