BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 12917039 · Received December 2, 2021

    Report

    Report Number
    2032227-2021-225896
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 23, 2021
    Report Date
    May 5, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000367053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. CUSTOMER RETURNED INSULIN PUMP FOR ALLEGED UNDER DELIVERY ANOMALY, REWIND ANOMALY, AND NO DELIVERY/OCCLUSION ALARM FOUND ON 11/23/2021. DEVICE PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT ACCURACY TEST, AND SELF TEST. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. NO OVER DELIVERY/REWIND ANOMALIES NOR NO DELIVERY ALARMS NOTED DURING TESTING. UNIT SUCCESSFULLY DOWNLOADED TO THUS AND CARELINK. CONFIRMED NORMAL BOLUS DELIVERY OF: 5.2U BOLUS ON NOV 23, 2021 AT 07:19, 0.8U BOLUS ON NOV 23, 2021 AT 12:09, 1.2U BOLUS ON NOV 23, 2021 AT 13:24, 5.9U BOLUS ON NOV 23, 2021 AT 15:52, 6.2U BOLUS ON NOV 23, 2021 AT 19:49, 3.5U BOLUS ON NOV 23, 2021 AT 22:44. NO CONFIRMED REWIND ANOMALY ALARMS IN THE PUMP DOWNLOADED HISTORY. CONFIRMED NO DELIVERY ALARM ON 10/23/2021 AT 00:53:30 DURING A BOLUS IN THE PUMP DOWNLOADED HISTORY. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE¿ON THE ELECTRONIC ASSEMBLY, MOTOR, OR FORCE SENSOR. MOTOR WAS TAKEN TO THE TEST BENCH WHERE IT REWOUND WITH NO ERRORS OR ALARMS NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE. IN SUMMARY, INSULIN PUMP PASSED REQUIRED TESTING. CUSTOMER ALLEGED FOR NO DELIVERY/OCCLUSION DURING BOLUS WAS FOUND IN THE INSULIN PUMP HISTORY, HOWEVER WAS NOT CONFIRMED DURING TESTING. CUSTOMER ALLEGATION FOR UNDER DELIVERY WAS NOT CONFIRMED. CUSTOMER ALLEGED FOR REWIND ANOMALY 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 · 0

    (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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER ALSO REPORTED THAT THERE WERE UNEXPLAINED NO DELIVERY ALARMS, SLOWER AND LOUDER DURING REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819618 630G INSULIN PUMP MMT-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL HG5E2AF 000000763000367053

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male