BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 9942175 · Received April 9, 2020

    Report

    Report Number
    3005862821-2020-00016
    Event Type
    Injury
    Date Received
    April 9, 2020
    Date of Event
    February 26, 2020
    Report Date
    March 10, 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#: D181026-1). PATIENT DID NOT RETURN METER, ONLY RETURNING HER STRIPS. RETAINED AND RETURN STRIPS (LOT#: D181026-1) WERE USED TO RE-TEST WITH OUR IN-HOUSE METER (SERIAL#: (B)(4)) AND CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A94, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A14, EXP. BY SEPT., 2020), AND RESULTS WERE SHOWN BELOW. RETAINED METER W/ RETAINED STRIPS: 58/55 (LEVEL LOW) AND 230/239 (LEVEL HIGH). RETAINED METER W/ RETURN STRIPS: 198/212 (LEVEL LOW) AND 327/364 (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 THE CLIENT 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

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 AROUND 3:00PM AT HOME. CALLER STATED THAT THEY TESTED THE END-USERS BLOOD GLUCOSE AND GOT A RESULT OF 169MG/DL, WHICH PROMPTED HER TO GIVE THE ENDUSER 24UNITS OF NOVOLOG. CALLER STATED THAT ABOUT 15 MINUTES AFTER GIVING HER INSULIN THE CALLER FOUND THE END-USER UNRESPONSIVE AND CALLED EMS. THE CALLER DID NOT TEST THE END-USERS BLOOD GLUCOSE AGAIN. THE END-USER DID NOT CONSUME ANY FOOD OR DRINK WHILE WAITING FOR EMS. EMS ARRIVED WITH IN 10MINUTES AND TESTED THE END-USERS BLOOD GLUCOSE AND GOT A RESULT OF 30MG/DL. THE ENDUSER WAS THEN TRANSPORTED TO (B)(6) LOCATED AT (B)(6). THE CALLER WAS UNSURE OF WHAT THE END-USERS BLOOD GLUCOSE WAS WHEN SHE ARRIVED AT THE HOSPITAL NOR DOES SHE KNOW WHAT TREATMENT WAS RECEIVED DUE TO HER STATING THAT SHE DID NOT GO TO THE HOSPITAL WITH THE END-USER. THE CALLER STATED THAT THE END-USER WAS AT THE HOSPITAL FOR 3 HOURS. THE END-USER WAS TOLD TO FOLLOW UP WITH HER PRIMARY DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409904 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D181026-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization