BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 5562211 · Received April 8, 2016

    Report

    Report Number
    3005862821-2016-00019
    Event Type
    Injury
    Date Received
    April 8, 2016
    Report Date
    March 10, 2016
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 (B)(4) ON MAR. 15,2013. THE SERIAL NUMBER OF THIS METER IS WITHIN THE RANGE FOR METERS HAD CRYSTAL ISSUE, HOWEVER IF METER WITH DEFECTED CRYSTAL, THE METER SHOULD HAVE INCONSISTENT POWER OR NO POWER, AND WON'T PRODUCE HIGHER READINGS. SO THIS METER SHOULDN'T CONSIDER HAVING A CRYSTAL PROBLEM. THE STRIP LOT #D140604-4 WAS MANUFACTURED ON JUNE 04, 2014 AND EXPIRED IN JUNE 2016. OK BIOTECH RECEIVED NO OTHER HIGHER READING COMPLAINTS FROM SAME MANUFACTURING BATCH OF STRIPS. BECAUSE 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. THE INVESTIGATION RESULTS WERE SENT TO OUR IMPORTER.

    Description of Event or Problem · 1

    OUR IMPORTER, (B)(4), RECEIVED A CALL ON 04/29/2015 REPORTING THAT WHEN PATIENT TESTED WITH THE PRODIGY METER THE RESULTS WERE 300MG/DL AND 400MG/DL. AT THE TIME OF THE CALL PATIENT'S DAUGHTER STATED THAT PATIENT WAS IN THE HOSPITAL FOR 3 DAYS. PATIENT'S DAUGHTER STATED THAT THE HOSPITAL'S METER WAS GIVING LOWER READINGS THAN THE PRODIGY METER. PATIENT'S NORMAL BLOOD GLUCOSE READING RANGE IS 120MG/DL. NO INFORMATION WAS GIVEN AS TO THE REASON WHY PATIENT WAS IN THE HOSPITAL. (B)(4) REPRESENTATIVE STATED THAT NO READINGS FOR 300-400MG/DL COULD BE FOUND IN THE METER MEMORY. PATIENT'S DAUGHTER'S RESPONSE WAS THAT EVERY TIME PATIENT'S BLOOD GLUCOSE READINGS WERE 300-400MG/DL THE METER WOULD NOT STORE ANY MORE READINGS SO SHE DELETED THE MEMORY AND THAT EVERY TIME THE METER WOULD GIVE A READING OF 450MG/DL THE METER WOULD NOT SAVE THE PREVIOUS READINGS UNTIL THE MEMORY IS DELETED. VARIOUS SECTIONS OF THIS REPORT ARE INCOMPLETE. PATIENT'S PHONE NUMBER HAS CHANGED AND CANNOT BE CONTACTED BY PHONE. (B)(4) COULD NOT RETRIEVE THE SUSPECT DEVICE FOR EVALUATION, THEREFORE (B)(4) REQUESTED FROM THE MANUFACTURER AN INTERNAL RECORD REVIEW FOR THE SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216830 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D140604-4

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization