BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1782KL 670G MM RPL

    MDR report key: 12245731 · Received July 29, 2021

    Report

    Report Number
    2032227-2021-174090
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    July 18, 2021
    Report Date
    November 10, 2021
    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

    EVENT DATE: JULY 18, 2021. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM. FUNCTIONAL TESTING TO BE PERFORMED/COMPLETED: THE INSULIN PUMP WAS RECEIVED WITH A CRACKED BATTERY TUBE THREADS, A SCRATCHED CASE, A CRACKED KEYPAD OVERLAY, A CRACKED CASE-CORNER OF BELT CLIP RAILS NEAR THE BATTERY TUBE COMPARTMENT AND A PILLOWING KEYPAD OVERLAY. THE TEST P-CAP/RESERVOIR DOES LOCK PROPERLY INSIDE THE RESERVOIR TUBE. THE INSULIN PUMP PASSED THE FUNCTIONAL TESTS, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND DELIVERY ACCURACY TEST AT 0.08710 INCHES. NO UNEXPECTED CRITICAL PUMP ERROR ALARM NOTED DURING THE TESTING. THE INSULIN PUMP HISTORY FILE/TRACES DOWNLOAD WAS SUCCESSFUL USING THUS. CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM, PUMP ERROR 4 ALARM WAS RECORDED ON: 07/18/2021 11:10:31.000 ALARM ALERT NOTIFICATION 07/18/2021 11:10:37.000 ALARM ALERT CLEARED AND PUMP ERROR 53 ALARM (LINE NUMBER = 5632 ; FILE NUMBER = 2005) WAS RECORDED ON: 07/18/2021 11:10:01.000 ALARM ALERT NOTIFICATION 07/18/2021 11:10:15.000 ALARM ALERT CLEARED CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM, PUMP ERROR 4 ALARM AND PUMP ERROR 53 ALARM (LINE NUMBER = 5632 ; FILE NUMBER = 2005) WERE RECORDED AND FOUND IN THE FORMATTED HISTORY FILE DUE TO SOFTWARE ERROR. THE INSULIN PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND NO LOOSE ELECTRONIC COMPONENTS NOTED. HOWEVER, CORROSION WAS FOUND ON THE ELECTRONIC ASSEMBLY. NO CORROSION OR MOISTURE DAMAGE ON THE FORCE SENSOR, MOTOR AND VIBRATOR ASSEMBLY NOTED. FAILURE ANALYSIS SUMMARY: THE INSULIN PUMP ALARMED CRITICAL PUMP ERROR (OPEN BOOK IMAGE), PUMP ERROR 4 ALARM AND PUMP ERROR 53 ALARM DUE TO SOFTWARE ERROR. CORROSION WAS FOUND ON THE ELECTRONIC ASSEMBLY. 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 SHOWED OPEN BOOK IMAGE ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147433 PUMP MMT-1782KL 670G MM RPL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1782KL HG4ES46 000000763000283599

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown