BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP MMT-551NAS

    MDR report key: 11626484 · Received April 7, 2021

    Report

    Report Number
    2032227-2021-132560
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 18, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000643169503663
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME OR A33 TEST, EXCESSIVE NO DELIVERY TEST AND DAT TEST AT 0.0874 INCHES. NO UNDER DELIVERY ANOMALY OR OVER DELIVERY ANOMALY NOTED. THE STOP (IDLE) CURRENT AND RUN CURRENT MEASUREMENT TESTS ARE WITHIN SPECIFICATION. DEVICE ALSO PASSED SELF TEST, OFF NO POWER ALARM TEST AND A21 ERROR TEST. THE LOW BATTERY ALARM AND OFF NO POWER ALARM FUNCTIONS PROPERLY. THE NO DELIVERY ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST AND OCCLUSION TEST. NO UNEXPECTED NO DELIVERY ALARM NOTED DURING TESTING. DEVICE PASSED TONE CHECK AND VIBRATE CHECK ON SELF TEST. NO AUDIO OR VIBRATE OR ABSENCE OF ALARM ANOMALIES NOTED DURING TESTING. THE TEST BATTERY WAS REMOVED AND REINSERTED WITH NO FAILED BATTERY TEST ALARM NOTED. NO DRIVE OR MOTOR ANOMALY, MOTOR ERROR ALARM OR UNEXPECTED MOTOR NOISE ANOMALY NOTED. THE MOTOR WAS TESTED OUTSIDE OF THE UNIT AND PASSED. DEVICE HAD INTERMITTENT BUTTON RESPONSE ON THE ACT BUTTON DUE TO FLATTENED DOME SWITCH (NO CREASE). NO BUTTON ERROR ALARM NOTED. DURING VISUAL INSPECTION, THE KEYPAD CONNECTOR ON THE LCD WAS FOUND LOCKED PROPERLY. DEVICE WAS MONITORED FOR 2 DAYS. NO RESET ALARM OR PUMP RESET ANOMALY NOTED. DEVICE UPLOADED PROPERLY USING CARELINK. DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT RESERVOIR TUBE CORNER, CRACKED RESERVOIR TUBE WINDOW AND A PARTIALLY BROKEN OFF RESERVOIR TUBE LIP. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. 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. 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 · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 400 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP BUTTONS WERE UNRESPONSIVE. CUSTOMER STATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARMS. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS. CUSTOMER STATED THAT THE INSULIN PUMP REJECTED NEW BATTERY. CUSTOMER STATED THAT THE INSULIN PUMP HAD GRINDING NOISES. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN CORRECTLY. THE INSULIN PUMP AND THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523169 530G INSULIN PUMP MMT-551NAS ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS A4551NASJ 000000643169503663

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other UNOMED-UNK| UNOMED-UNK