BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7085897 · Received December 6, 2017

    Report

    Report Number
    3005862821-2017-00131
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    November 6, 2017
    Report Date
    November 7, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF RETURNED METER, THE RESULT WAS 16.6¿A. THE CRITERIA IS <55¿A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND RETURNED STRIPS (STRIP LOT NUMBER: D160926-1 ). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 151/248 MG/DL, FOR LEVEL HIGH WERE 322/324 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~290 MG/DL. ALL RESULTS WERE OUT OF THE ACCEPTANCE RANGE. THE DESICCANT IN THE TEST STRIP VIAL WERE DISCOLORED. WE TESTED THE RETAIN STRIPS OF SAME BATCH (STRIP LOT NUMBER: D160926-1) FROM OUR WAREHOUSE. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 55/52 MG/DL; FOR LEVEL HIGH WERE 240/251 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.

    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 (B)(4) ON 12/29/2016. THE STRIP LOT # D160926-1 WAS MANUFACTURED ON 09/26/2016 AND EXPIRED IN 09/2018. OK BIOTECH RECEIVED NO COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS . OKB TESTED THE RETAIN STRIPS TEST FROM OUR WAREHOUSE WITH OUR STANDARD METER AND CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 65/67 MG/DL; FOR LEVEL HIGH WERE 253/247 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 . 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.

    Description of Event or Problem · 1

    THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00131 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON DEC. 20, 2017 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 4:50 PM AFTER THE END USER ALLEGED THAT HIS PRODIGY DIABETES METER WAS READING 100 MG/DL HIGHER THAN NORMAL. THE END USER EXPERIENCED SWEATING, SHAKING AND WAS DISORIENTED ACCOMPANIED WITH A BLOOD GLUCOSE READING OF 132 MG/DL. HE WAS IMMEDIATELY TAKEN TO THE ER AND UPON ARRIVAL A BLOOD GLUCOSE TEST WAS PERFORMED WITH THE HOSPITAL'S METER AND THE RESULT WAS 21 MG/DL. THE END USER WAS ADMINISTERED DEXTROSE TO BOOST HIS BLOOD GLUCOSE LEVEL. AFTER SEVERAL HOURS IN THE ER THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 98 MG/DL AND HE WAS ALSO INSTRUCTED TO FOLLOW-UP WITH HIS PCP. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868934 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 52800 - D160926-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention ADVAIR| ALBUTEROL| ALDACTONE| ASPIRIN| BUMETANIDE| BUPRENORPHINE| COREG| FENOFIBRATE| FLOMAX| IRON| ISOSORBIDE| LEVEMIR| LISINOPRIL| NEURONTIN| PLAVIX| PROTONIX| RANEXA| SEROQUEL| ZOLOFT