BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1880L MM770G BLE MG

    MDR report key: 13494747 · Received February 9, 2022

    Report

    Report Number
    2032227-2022-110989
    Event Type
    Injury
    Date Received
    February 9, 2022
    Date of Event
    February 5, 2022
    Report Date
    June 14, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000439866
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. ON 05-FEB-2022 CUSTOMER ALLEGED INSULIN PUMP RECEIVED CRITICAL PUMP ERROR(OPEN BOOK IMAGE) ALARM AND BLANK DISPLAY. ALLEGATIONS TO HIGH BGS NOTED. DEVICE RECEIVED WITH A FROZEN DISPLAY WITH FLASHING MEDTRONIC LOGO. RESET THE PUMP THREE TIMES TO DETERMINE FLASHING MEDTRONIC LOGO IS PERMANENT AND IT WAS CONFIRMED FLASHING MEDTRONIC LOGO PERMANENT. UNIT UNABLE TO PERFORM DISPLACEMENT TEST, REWIND, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST OR VERIFY CRITICAL PUMP ERROR(OPEN BOOK IMAGE) DUE TO FROZEN DISPLAY ANOMALY. DEVICE WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON THE PCBA 1, AND PCBA 2. UNABLE TO DOWNLOAD PUMP'S HISTORY AND TRACE FILES USING THUMP DUE TO FROZEN DISPLAY ANOMALY. P-CAP / RESERVOIR LOCKS PROPERLY INTO PLACE. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, CRACKED CASE, CRACKED CASE(BATTERY TUBE), CRACKED CASE-CORNER OF BELT CLIP RAILS, AND BATTERY TUBE THREADS-CRACKED. IN SUMMARY, CUSTOMER ALLEGATION FOR PUMP RECEIVING CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS UN-CONFIRMED DUE TO FROZEN DISPLAY (FLASHING MEDTRONIC LOGO). BLANK DISPLAY NOT CONFIRMED. FROZEN DISPLAY (FLASHING MEDTRONIC LOGO) CONFIRMED DUE TO CORRODED ELECTRONIC ASSEMBLIES. UNABLE TO DOWNLOAD PUMP'S HISTORY AND TRACE FILES USING THUMP DUE TO FROZEN DISPLAY ANOMALY.UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BGS. 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. 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 · 0

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS OVER 600 MG/DL WHICH WAS TREATED WITH MANUAL INJECTION. IT WAS UNKNOWN IF THE AUTO MODE FEATURE WAS ACTIVE OR NOT. CUSTOMER STATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. CUSTOMER STATED THE CONTACTS ON BATTERY CAP WAS NEITHER MISSING NOR DAMAGED. CUSTOMER INSERTED NEW BATTERY AND DISPLAY RETURNED AFTER INSULIN PUMP RESTART. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A CRITICAL PUMP ERROR ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087129 PUMP MMT-1880L MM770G BLE MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880L HG5J4GL 000000763000439866

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other FRN-UNK-RSVR, UNOMED SET