BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POGO AUTOMATIC BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 11639349 · Received April 8, 2021

    Report

    Report Number
    3013750448-2021-00002
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    March 8, 2021
    Report Date
    April 7, 2021
    Manufacturer
    INTUITY MEDICAL, INC.
    Product Code
    NBW
    PMA / PMN Number
    K181316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE REPORTED EVENT, DHR, AND LABELING WERE PERFORMED. NO ISSUES WERE IDENTIFIED AS PART OF THE DHR AND LABELING REVIEW. REVIEW OF THE EVENT FOUND THE CUSTOMER TOOK INSULIN TO LOWER HIS BLOOD SUGAR LEVELS DESPITE RECEIVING A NORMAL READING. THIS CUSTOMER HAD BEEN SELF-MANAGING HIS DIABETES FOR OVER 25 YEARS WITHOUT A METER AND HAD JUST STARTED USING THE POGO AUTOMATIC METER TO MONITOR HIS BLOOD GLUCOSE LEVELS. IN ADDITION, THE CUSTOMER¿S SON REQUESTED CONTROL SOLUTION WHICH VERIFIED THAT BOTH METER AND THE CARTRIDGES WERE FUNCTIONING AS INTENDED AT THE TIME OF THE CONTROL SOLUTION TEST. ON (B)(6) 2021, THE CUSTOMER'S SON REPORTED THAT HIS FATHER IS HAPPY WITH THE POGO AUTOMATIC METER AND THAT THE EVENT WAS NOT CAUSED BY THE METER.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE CUSTOMER'S SON CALLED IN TO CUSTOMER SUPPORT TO INQUIRE ABOUT CONTROL SOLUTION AFTER READING ABOUT IT IN THE USER MANUAL. CUSTOMER SUPPORT STATED THAT CONTROL SOLUTIONS ARE AVAILABLE UPON REQUEST. THE CUSTOMER'S SON STATED THAT HIS FATHER HAS MANAGED HIS DIABETES WITHOUT A METER FOR THE PAST 25 YEARS AND THAT THE POGO METER WAS THE FIRST METER HE HAS EVER USED. HE WENT ON TO STATE THAT HIS FATHER IS GETTING FAMILIAR WITH USING THE METER AND TEST RESULTS WERE RANGING FROM 40 MG/DL TO 350 MG/DL. HIS SON WENT ON TO MENTION THAT THE NIGHT PRIOR TO CALLING IN, HIS FATHER HAD TAKEN INSULIN AFTER RECEIVING A NORMAL READING ON HIS POGO AUTOMATIC METER (TEST RESULT WAS NOT KNOWN BY CUSTOMER'S SON). THIS CAUSED HIS BLOOD SUGAR TO DROP, AND HE BEGAN TO SHAKE AND ACT IRRATIONALLY. HIS WIFE CALLED EMT SERVICES WHO WERE ABLE TO INCREASE HIS BLOOD SUGAR. CUSTOMER SUPPORT SENT THE CUSTOMER CONTROL SOLUTION. ON (B)(6) 2021, THE CUSTOMER¿S SON REPORTED THAT THE CONTROL SOLUTION WAS RECEIVED AND USED TO TEST THE POGO AUTOMATIC METER WITH CARTRIDGES. THE CONTROL SOLUTION TEST PASSED. HE WENT ON TO SAY THAT HIS FATHER REALLY LIKES THE METER AND THAT THE EVENT THAT HAD OCCURRED WAS NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530087 POGO AUTOMATIC BLOOD GLUCOSE MONITORING SYSTEM BLOOD GLUCOSE METER NBW INTUITY MEDICAL, INC. 00856176008001 150339562

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention