BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MINIMED RESERVOIR

    MDR report key: 10482284 · Received September 1, 2020

    Report

    Report Number
    MW5096371
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    August 28, 2020
    Report Date
    August 28, 2020
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS IS THE THIRD TIME IN THE LAST FEW MONTHS I HAVE HAD THIS ISSUE, I HAVE CALLED MEDTRONIC ALL THREE TIMES AND HAVE NOT GOTTEN AN ACCEPTABLE RESPONSE. WHEN FILLING A NEW INSULIN RESERVOIR FOR MY 630G INSULIN PUMP, I GET AIR BUBBLES IN LINE THAT WILL NOT STOP. EACH TIME THIS HAPPENS I USE ONE FROM A NEW LOT NUMBERED BOX AND ALL IS FINE. I HAVE BEEN DOING THIS FOR AROUND 15 YEARS, AND I AM NOT DOING ANYTHING DIFFERENTLY NOW. NORMALLY IT TAKES ABOUT 18 UNITS OF INSULIN TO CLEAR TUBING OF ANY AIR BUBBLES, WHEN I HAVE HAD THE ISSUE IT HAS TAKEN OVER 45 UNITS AND STILL THERE IS AIR IN LINE. THE PUMP AUTOMATICALLY MAKES ME START OVER. MEDTRONIC ADVICE THIS LAST TIME WAS TO CONTACT MY DOCTOR, WHICH I HAVE DONE. IT APPEARS TO ME THAT THE TWO BLACK RUBBER SEALS ON BOTTOM OF RESERVOIR ARE ALLOWING AIR INTO VIAL. I DO HAVE A VIDEO OF THE ISSUE BUT IS TOO LARGE A FILE TO ADD TO THIS FORM. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945251 MEDTRONIC MINIMED RESERVOIR AUTOMATED INSULIN DOSING , THRESHOLD SUSPEND OZO MEDTRONIC MINIMED MMT332A HG3C2AY
    945252 MEDTRONIC MINIMED RESERVOIR AUTOMATED INSULIN DOSING , THRESHOLD SUSPEND OZO MEDTRONIC MINIMED MMT332A HG3KVH6
    945253 MEDTRONIC MINIMED RESERVOIR AUTOMATED INSULIN DOSING , THRESHOLD SUSPEND OZO MEDTRONIC MINIMED MMT332A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR