BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10591858 · Received September 28, 2020

    Report

    Report Number
    3005862821-2020-00053
    Event Type
    Injury
    Date Received
    September 28, 2020
    Date of Event
    August 21, 2020
    Report Date
    September 11, 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

    NO NON-CONFORMITY WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF THE SUSPECTED METER (SERIAL#: (B)(4) AND STRIPS (LOT#: D171226-1). METER SETTING AND ALL FUNCTIONS OF THE SUSPECTED DEVICE WERE RE-TESTED, AND ALL OF THEM WERE OPERATED PROPERLY. STANDBY CURRENT OF THE DEVICE WAS RE-CHECKED AND THE CURRENT (0.9 UA) MET ACCEPTANCE CRITERIA (< 55 UA). STRIPS WERE MANUFACTURED ON 12/26/2017 AND WERE EXPIRED IN 12/2019. BECAUSE THE SUSPECTED STRIPS WERE EXPIRED AND OUT OF SPECIFICATIONS, THE SUSPECTED METER WAS TESTED BY USING ANY RETAINED STRIPS (LOT#: D190819-1) AND CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A95, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A15, EXP. BY DEC., 2020), AND RESULTS (LEVEL LOW: 58/52; LEVEL HIGH: 281/287) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 35~85 ; LEVEL HIGH: 220~330). EXPIRED STRIPS MAY CAUSE INACCURATE BLOOD GLUCOSE READINGS. WARNING INFORMATION REGARDING NOT TO USE EXPIRED STRIPS WAS DISCLOSED IN USER'S MANUAL AND STRIP LABELING TO AVOID THIS PROBLEM. FURTHERMORE, THE EXPIRATION DATE WAS SHOWN CLEARLY ON THE STRIP LABEL, STRIP BOX AND KIT BOX. THEREFORE, THE ROOT CAUSE OF THE COMPLAINT RESULTED FROM USER'S IMPROPER OPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY 2 FALSE POSITIVE RESULTS WERE OBTAINED ON A RESIDENT AND A STAFF MEMBER. A REPEAT TEST WAS PERFORMED USING A PCR TEST METHOD AND THE RESULTS WERE NEGATIVE. THE CUSTOMER STATED THE PATIENTS TESTED WERE ASYMPTOMATIC. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THE RESIDENT WAS MOVED TO THE COVID ISOLATION ROOM AND THE STAFF MEMBER WAS QUARANTINED AT HOME UNTIL PCR NEGATIVE RESULT WAS OBTAINED. EUA # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058534 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D171226-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization