PUMP MMT-1884L MM780G BLE 3.0 MG/ML (MEDTRONIC PUERTO RICO OPERATIONS CO.) — Malfunction
A malfunction was reported involving the Medtronic MiniMed 780G (MMT-1884L) insulin pump. At the time of the report, the manufacturer had not yet received the device for analysis and could not determine if the device caused or contributed to the event.
Regulatory affairs and post-market surveillance teams managing insulin delivery systems and manufacturers operating under specific FDA variances for multi-site reporting.
This report highlights the ongoing reporting obligations under 21 CFR Parts 4 and 803 even when device analysis is pending. The mention of 'Variance 5' suggests a specific administrative arrangement between Medtronic manufacturing sites for MDR processing, which may be of interest to compliance professionals tracking site-specific reporting obligations.
Regulatory teams should ensure that MDRs filed under administrative variances (such as site-specific MedWatch number assignments) maintain clear traceability. QA departments should monitor for the completion of the device analysis following the return of the hardware to update the filing as required by 21 CFR 803.
Event type: Malfunction. Device: PUMP MMT-1884L MM780G BLE 3.0 MG/ML by MEDTRONIC PUERTO RICO OPERATIONS CO.. 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. 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
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