PUMP MMT-1880L MM770G BLE MG (MEDTRONIC PUERTO RICO OPERATIONS CO.) — Injury
The FDA recorded an adverse event involving an injury associated with the PUMP MMT-1880L MM770G BLE MG manufactured by Medtronic Puerto Rico Operations Co. The source identifies the event type as an injury but does not specify the medical nature or cause of the incident.
This affects Medtronic Puerto Rico Operations Co., specifically personnel responsible for the MM770G product line, as well as regulatory compliance and clinical safety officers managing insulin delivery systems.
The classification of this event as an 'Injury' suggests a potential functional failure or user-interface issue that led to patient harm. While the source provides limited detail on the severity, this report indicates a post-market safety signal that may require a root cause analysis and could lead to increased regulatory scrutiny of the device's Bluetooth Low Energy (BLE) integration or pumping mechanism.
QA and post-market teams should review internal complaint handling for this specific model line and ensure timely reporting of similar events. Regulatory affairs should monitor for potential field safety corrective actions if injury patterns persist.
Event type: Injury. Device: PUMP MMT-1880L MM770G BLE MG by MEDTRONIC PUERTO RICO OPERATIONS CO..
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