BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782K 670G V4.11 MM

    MDR report key: 12187297 · Received July 19, 2021

    Report

    Report Number
    2032227-2021-169075
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    July 9, 2021
    Report Date
    January 7, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000264727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 07/09/2021 THE CUSTOMER ALLEGED POWER LOSS ALARM. THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. DEVICE RECEIVED WITH PILLOWING KEYPAD OVERLAY DURING THE VISUAL INSPECTION. THUS WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. THE POWER MANAGEMENT GRAPH CONFIRMED THE UNLOADED VOLTAGE (UL VLITH) AND LOADED VOLTAGE (LOADED VLITH) WAS WITHIN SPECIFIC RANGE. IN FURTHER FULL REVIEW IN THE DEVICE HISTORY FOUND NO POWER LOSS ALARM ON THE EVENT DATE OF 07/09/2021 HOWEVER, FOUND LOW BATTERY ALARMS ON 07/08/2021 AT 03:34 AND 18:02, OFF NO POWER ALARMS ON 07/08/2021 AT 13:36 AND 07/09/2021 AT 04:04 AND 04:14, BATTERY OUT LIMIT ALARMS ON 07/09/2021 AT 04:58, 17:07, AND 17:08, AND CHANGE BATTERY FAULT ALARMS ON 07/08/2021 AT 13:05 AND ON 07/09/2021 AT 3:33. DEVICE PASSED SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND DISPLACEMENT TEST. NO UNEXPECTED LOW BATTERY, OFF NO POWER, CHANGE BATTERY FAULTS, POWER LOSS, AND BATTERY OUT LIMIT ALARMS DURING TESTING. IN SUMMARY, INSULIN PUMP PASSED REQUIRED TESTING. CUSTOMER ALLEGED FOR POWER LOSS ALARM WAS NOT CONFIRMED. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD POWER LOSS ALARM. INSULIN PUMP WAS ABLE TO CLEAR THE ALARM. CUSTOMER DID NOT RECEIVE REQUEST TO REWIND PUMP. CUSTOMER RECEIVED MULTIPLE POWER LOSS ALARMS WHEN BATTERIES ARE OUT OF THE PUMP LESS THAN 10 MINUTES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090751 PUMP MMT-1782K 670G V4.11 MM ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782K HG44C00 000000763000264727

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown