BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7127889 · Received December 19, 2017

    Report

    Report Number
    3005862821-2017-00139
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 18, 2017
    Report Date
    November 18, 2017
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE DEVICE WAS NOT RETURNED TO OK BIOTECH, THEREFORE, WE WERE UNABLE TO PERFORM FURTHER TESTING ON THE SUSPECTED DEVICE. OK BIOTECH REVIEWED THE MANUFACTURING RECORD OF THIS SUSPECTED DEVICE (METER SERIAL NUMBER # (B)(4)), AND THE METER WAS QUALIFIED AND RELEASED BY THE QUALITY CONTROL DEPARTMENT AND SHIPPED TO PDC ON 02/23/2017. THE STRIP LOT # D161006-1 WAS MANUFACTURED ON 10/06/2016 AND EXPIRED IN 10/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . WE ARE UNABLE TO CONFIRM THE COMPLAINT BECAUSE DEVICE WAS NOT RETURNED AND NO FURTHER INFORMATION FROM CUSTOMER HAS BEEN RECEIVED, THIS MATTER HAS TO BE CLOSED OUT WITH UNDETERMINED ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE AND STRIPS WERE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS1.2A. THE CRITERIA IS LESS THAN 55A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND PATIENT'S RETURNED STRIPS (STRIP LOT NUMBER: D161006-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE HI/HI MG/DL, FOR LEVEL HIGH WERE HI/HI MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30-80 MG/DL; LEVEL HIGH 190-290 MG/DL. ALL RESULTS WERE HI. THE DESICCANT IN THE TEST STRIP VIAL WERE DISCOLORED. WE TESTED THE RETAIN STRIPS TEST FROM OUR WAREHOUSE( SAME AS PATIENT'S STRIP LOT NUMBER:D161006-1) WITH SUSPECTED METER AND IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 60/68 MG/DL; FOR LEVEL HIGH WERE 270/266 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30-80 MG/DL; LEVEL HIGH 190-290 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. ACCORDING TO ABOVE TESTS, WE FOUND THE METER WAS OPERATED WITHIN SPECIFICATION BUT RESULT OF INCORRECT READINGS FROM PATIENT'S STRIP MIGHT BECAUSE PATIENT STORED THE STRIPS IN A UNCONTROLLED OR IMPROPER ENVIRONMENT AND LEAD TO STRIPS MOIST AND PRODUCED INCORRECT HIGH READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 4:00 PM AFTER THE END USER ALLEGED THAT SHE RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HIS PRODIGY DIABETES METER. THE END USER RECEIVED A BLOOD GLUCOSE RESULT OF "HI" ACCOMPANIED WITH SYMPTOMS OF INCONTINENCE AND OUT OF CONCERN THE PARAMEDICS WERE CALLED. ONCE THE PARAMEDICS ARRIVED THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND RECEIVED A RESULT OF 127 MG/DL. THE END USER RECEIVED A DIET COKE, PUDDING AND POTATO CHIPS. SHE WAS TRANSPORTED TO THE ER AND UPON ARRIVAL HER BLOOD GLUCOSE READING WAS 104 MG/DL. NO FURTHER TREATMENTS OR TEST WERE NECESSARY DUE TO THE FACT THAT HER BLOOD GLUCOSE READING WAS WITHIN NORMAL RANGE. AFTER 2 HOURS IN THE ER SHE WAS DISCHARGED AND INSTRUCTED TO FOLLOW-UP WITH HER PCP. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00139 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON (B)(6) 2017 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909456 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D161006-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention