BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10591857 · Received September 28, 2020

    Report

    Report Number
    3005862821-2020-00052
    Event Type
    Injury
    Date Received
    September 28, 2020
    Date of Event
    August 23, 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
    CA, 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#: D191021-2). 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). RETURN AND RETAINED STRIPS (LOT#: D191021-2) WERE RE-TESTED BY USING RETURN (SERIAL#: (B)(4)) AND RETAINED (SERIAL#: OK-A QC-01) METERS WITH CONTROL SOLUTIONS (LEVEL LOW: BATCH# 8AH1A95, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A15, EXP. BY DEC., 2020), RESPECTIVELY, AND RESULTS WERE SHOWN BELOW. RETURN METER W/ RETURN STRIPS: 153/180 (LEVEL LOW) AND 362/311 (LEVEL HIGH). RETURN METER W/ RETAINED STRIPS: 67/63 (LEVEL LOW) AND 291/299 (LEVEL HIGH). RETAINED METER W/ RETURN STRIPS: 124/182 (LEVEL LOW) AND 325/320 (LEVEL HIGH). RETAINED METER W/ RETAINED STRIPS: 65/68 (LEVEL LOW) AND 298/277 (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 8-23-2020 AROUND 12:00AM AT HOME. CALLER STATED THAT THE END-USER TESTED HER BLOOD GLUCOSE WITH HER PRODIGY METER AND RECEIVED A RESULT OF 180MG/DL, CALLER SAID SHE TESTED AGAIN AND RECEIVED A RESULT OF 175MG/DL. THE CALLER SAID THAT THE END-USER HAD HUMALOG BEFORE DINNER AND HER BLOOD PRESSURE MEDICATION. CALLER SAID THE END-USER WAS SWEATY SHAKING AND WAS INCOHERENT WITH SLURRED SPEECH. PARAMEDICS WERE CALLED A FEW MINUTES AFTER TESTING WITH HER PRODIGY METER. CALLER STATED THAT THERE WAS NO FOOD DRINK OR MEDICATION CONSUMED WHILE WAITING FOR THE PARAMEDICS TO ARRIVE. PARAMEDICS ARRIVED ABOUT 5-10MINUTES AND TESTED THE END-USERS BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 35MG/DL, NO ADDITIONAL TESTS WERE PERFORMED WITH THE PRODIGY METER. PARAMEDICS ADMINISTERED A GLUCOSE INJECTION AND TRANSPORTED THE END-USER TO (B)(6) HOSPITAL LOCATED AT (B)(6). UPON ARRIVING AT THE HOSPITAL, THE END-USERS BLOOD GLUCOSE WAS 60MG/DL. THE END-USER WAS GIVEN MORE GLUCOSE AND A PEANUT BUTTER SANDWICH. SHE WAS AT THE HOSPITAL FOR 122 HOURS AND WAS TOLD TO FOLLOW UP WITH HER PRIMARY DOCTOR WHEN SHE WAS DISCHARGED. THE END-USER TAKES HUMALOG ON A SLIDING SCALE THAT IS AS FOLLOWS: 80-125MG/DL 5 UNITS, 126-175MG/DL 6 UNITS, 176- 225MG/DL 7 UNITS, 226-275MG/DL 8 UNITS, 276-325MG/DL 9 UNITS, 326-375MG/DL 10 UNITS, 376-425MG/DL 11 UNITS, ANYTHING HIGHER THAN 425MG/DL NOTIFY THE DOCTOR. THE CALLER WAS UNSURE OF WHAT THE END-USERS BLOOD GLUCOSE WAS WHEN SHE WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058533 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D191021-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization AMITRIPTYLINE| AMLODIPINE| AURYXIA| CARVEDILOL| CLOPIDOGREL| GABAPENTIN| HUMALOG| HYDRALAZINE| LANTUS| MIRTAZAPINE| SEVELAMER CARBONATE| STOOL SOFTENER| TELMISARTAN| TRAMADOL