BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782KL 670G MM RPL

    MDR report key: 12171999 · Received July 15, 2021

    Report

    Report Number
    2032227-2021-167864
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    July 7, 2021
    Report Date
    May 4, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING=BLACK CUSTOMER COMPLAINED ON (B)(6) 2021 THE INSULIN PUMP ALARMED PUMP ERROR 3. INSULIN PUMP PASSED THE SELF TEST AND DISPLACEMENT TEST. NO PUMP ERROR 3 ALARMS NOTED DURING TESTING. INSULIN PUMP SUCCESSFULLY DOWNLOAD TO THUS. HOWEVER, THE FORMATTED HISTORY FILE CONFIRMED THE INSULIN PUMP ALARMED PUMP ERROR 3 ON (B)(6) 2021 01:56:44.000 AND PUMP ERROR 54 (LINE NUMBER 202 FILE NUMBER 32149) ON (B)(6) 2021 01:57:26.000 DUE TO MOISTURE DAMAGE TO THE ELECTRICAL BOARD. NO MOISTURE DAMAGE NOTED TO THE MOTOR ASSEMBLY PER VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: CORRODED ELECTRONIC ASSEMBLIES, SCRATCHED CASE, PILLOWING KEYPAD OVERLAY AND CRACKED CASE CORNER OF THE BELT CLIP RAILS NEAR THE BATTERY COMPARTMENT, CRACKED BATTERY TUBE THREADS, CRACKED KEYPAD OVERLAY AND STAINED SERIAL NUMBER LABEL. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. NO PUMP ERROR 3 ALARMS NOTED DURING TESTING. HOWEVER, THE FORMATTED HISTORY FILE CONFIRMED THE INSULIN PUMP ALARMED PUMP ERROR 3 ON (B)(6) 2021 01:56:44.000 AND PUMP ERROR 54 (LINE NUMBER 202 FILE NUMBER 32149) ON (B)(6) 2021 01:57:26.000 DUE TO MOISTURE DAMAGE TO THE ELECTRICAL BOARD. 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 A PUMP ERROR ALARM. CUSTOMER STATED THAT THEY ABLE TO CLEAR THE ALARM. CUSTOMER'S REPORTED THEY RECEIVED REQUEST TO REWIND INSULIN PUMP BUT UNABLE TO COMPLETE REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED TO ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075151 PUMP MMT-1782KL 670G MM RPL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782KL HG4HF8V 000000763000283599

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown