BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1715KM 630G 3ML BLACK MEDI  

    MDR report key: 8806320 · Received July 19, 2019

    Report

    Report Number
    2032227-2019-32568
    Event Type
    Injury
    Date Received
    July 19, 2019
    Date of Event
    February 9, 2019
    Report Date
    September 3, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169873834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED WITH A BLANK DISPLAY DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. UNABLE TO PERFORM THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST, AND THE DAT TEST OR VERIFY KEYPAD UNRESPONSIVE/BUTTON ERROR ALARM DUE TO THE BLANK DISPLAY. MOISTURE DAMAGE WAS ALSO FOUND ON THE MOTOR AND FORCE SENSOR DURING VISUAL INSPECTION.

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPOGLYCEMIA. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 54 MG/DL. CUSTOMER ALSO STATED THAT SCROLL BAR WAS NOT MOVING WITH NO INPUT AND CENTER, UP AND DOWN ARROWS BUTTONS WAS UNRESPONSIVE. IT WAS ALSO STATED THAT THE BUTTON WAS NOT UNRESPONSIVE DURING AN EASY BOLUS ATTEMPT. CUSTOMER TREATED HYPOGLYCEMIA WITH CEREAL AND YOGURT AND DECLINED TROUBLESHOOTING FOR HYPOGLYCEMIA. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602401 PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KM HG2F94K 00643169873834

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other FRN-UNK-RSVR, UNOMED INF SET