BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-1885A OUS BLE PUMP MMOL/L

    MDR report key: 20061996 · Received August 26, 2024

    Report

    Report Number
    2032227-2024-225844
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    August 3, 2024
    Report Date
    November 27, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE THUMP SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. IN FURTHER FULL REVIEW FOUND MULTIPLE NO DELIVERY ALARMS IN THE PUMP HISTORY ON (B)(6) 2024 FROM 10:50:23.000 UNTIL 11:53:00.000 DURING BOLUS DELIVERIES. PUMP PASSED THE SELF TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. NO UNEXPECTED NO DELIVERY ALARM/INSULIN FLOW BLOCKED DURING TESTING. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO COMPONENT OR MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY, MOTOR ASSEMBLY AND FORCE SENSOR. THE FORCE SENSOR OFFSET MEASURED WITHIN SPEC RANGE DURING TESTING (22.9 MV). THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. PUMP RECEIVED WITH PILLOWING KEYPAD OVERLAY, CRACKED SELECT BUTTON KEYPAD OVERLAY AND MINOR SCRATCHED LCD WINDOW DURING THE VISUAL INSPECTION. NO CRACKS ON THE FRONT OF THE PUMP NOTED. IN SUMMARY, PUMP PASSED REQUIRED TESTING. INSULIN FLOW BLOCK ALARM/NO DELIVERY ALARM WAS RECORDED IN THE PUMP HISTORY, HOWEVER, INSULIN FLOW BLOCK ALARM/NO DELIVERY ALARM WAS NOT CONFIRMED DURING TESTING. THE FORCE SENSOR IS WITHIN SPECIFICATION. COSMETIC DAMAGE AT FRONT OF THE PUMP (CRACK) WAS NOT CONFIRMED, HOWEVER, OTHER COSMETIC DAMAGE WAS NOTED. UNABLE TO VERIFY CUSTOMER ALLEGED FOR HIGH BG. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. THE REPORTED DEVICE IS NOT MARKETED IN THE UNITED STATES, BUT IT IS A SAME/SIMILAR DEVICE TO ONE THAT IS MARKETED INSIDE THE UNITED STATES. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED DAMAGE (PHYSICAL OR COSMETIC), NO DELIVERY/OCCLUSION ALARM. THE CUSTOMER REPORTED BLOOD GLUCOSE VALUE OF 21.4 MMOL/L. THE CUSTOMER REPORTED HYPERGLYCEMIA TREATED WITH INSULIN PUMP (SUBCUTANEOUS INSULIN INFUSION). THE EVENT INVOLVED PRODUCT(S) MMT-1885A. TROUBLESHOOTING WAS PERFORMED. CUSTOMER REPORTED INSULIN FLOW BLOCKED ALARM (PAST/RESOLVED EVENT). ISSUE WAS RESOLVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-1885A WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231965 PUMP MMT-1885A OUS BLE PUMP MMOL/L AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1885A NG3419820H

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Unknown