BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1715KM 630G 3ML BLACK MEDI  

    MDR report key: 8784380 · Received July 12, 2019

    Report

    Report Number
    2032227-2019-29102
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    July 3, 2019
    Report Date
    August 8, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169873834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DELIVERY ACCURACY TEST AT 0.08720 INCHES. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM OR NO DELIVERY ALARM NOTED. INSULIN PUMP RECEIVED WITH SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND MINOR SCRATCHED LCD WINDOW. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD NO DELIVERY AND ABSENCE OF OCCLUSION ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THEY INSERTED INFUSION SET AND THERE WILL BE UNDER DELIVERY OF INSULIN TO HIS BODY. CUSTOMER WAS NOT ABLE TO TROUBLESHOOT AT THE TIME OF CALL. CUSTOMER REPORTS ALARM DID NOT OCCUR DURING FILL TUBING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578507 PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KM HG1MK0Y 00643169873834

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR