BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWS

    MDR report key: 12672483 · Received October 21, 2021

    Report

    Report Number
    2032227-2021-208218
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    October 14, 2021
    Report Date
    December 12, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    000000763000161286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER COMPLAINT NOTES, STATED NO DELIVERY ALARMS. DEVICE PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND EXCESSIVE NO DELIVERY TEST. NO EXCESSIVE NO DELIVERY/OCCLUSION ALARM NOTED. DEVICE HISTORY DOWNLOAD USING THDS WAS SUCCESSFUL. HOWEVER, ON THE REPORTS DATA SHOWN: (B)(6) 2021 01:00:00 BASAL SEGMENT START EVENT, (B)(6) 2021 08:26:42 SELF TEST, (B)(6) 2021 08:28:55 REWIND, (B)(6) 2021 08:30:03 MANUAL PRIME, DELIVERED 3.8 UNITS, (B)(6) 2021 08:30:23 BASAL SEGMENT START EVENT, (B)(6) 2021 08:30:45 NORMAL BOLUS, (B)(6) 2021 00:00:00 DAILY INSULIN TOTAL 30.225 UNITS. NO MOISTURE DAMAGE FOUND ON THE ELECTRONICS, MOTOR, BATTERY TUBE AND VIBRATOR ASSEMBLY NOTED. DEVICE RECEIVED WITH MINOR SCRATCHED LCD WINDOW, BROKEN BELT CLIP SLOT, STAINED END CAP STICKER AND CRACKED RESERVOIR TUBE LIP. THE TEST P-CAP/RESERVOIR DOES LOCK INTO PLACE. 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 RECURRING NO DELIVERY ALARMS. CUSTOMER WAS ASSISTED WITH TROUBLESHOOT BUT THE ISSUE WAS NOT RESOLVED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575800 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754WWS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWS B8754WWSJ 000000763000161286

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown