MINIMED 720G OUS BLE CONNECT 3.0 MMOL/L (MEDTRONIC PUERTO RICO OPERATIONS CO.) — Malfunction
A malfunction was reported involving the MiniMed 720G OUS BLE Connect 3.0 mmol/L, a device manufactured in Puerto Rico and marketed outside the United States. Although the device has not yet been returned for analysis, it is considered a same or similar device to products marketed within the U.S.
Manufacturers of insulin pumps and glucose monitoring systems, specifically those with international manufacturing sites and OUS marketing footprints for devices similar to U.S. models.
This report underscores the FDA requirement to report OUS malfunctions for devices 'same or similar' to U.S.-marketed products. The use of a MedWatch number from a different site (Northridge) under a specific variance highlights the complexity of multi-site regulatory reporting structures. Until the device is returned and analyzed, the root cause remains undetermined, necessitating robust reverse logistics and failure analysis protocols.
Ensure that MDR reporting procedures for international sites correctly account for internal site variances and MedWatch numbering protocols. Review cross-border complaint handling workflows to ensure evidence collection is prioritized for devices not marketed in the U.S. that are 'same or similar' to U.S.-cleared models.
Event type: Malfunction. Device: MINIMED 720G OUS BLE CONNECT 3.0 MMOL/L by MEDTRONIC PUERTO RICO OPERATIONS CO.. 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. 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
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