PUMP 1886 780G OUS BLE PUMP MG/DL (MEDTRONIC PUERTO RICO OPERATIONS CO.) — Malfunction
A malfunction was reported regarding the PUMP 1886 780G OUS BLE PUMP MG/DL manufactured by Medtronic Puerto Rico Operations Co. While the specific device is not marketed in the United States, it is functionally similar to a U.S.-marketed device and was reported via a MedWatch number assigned to a sister site under a reporting variance.
Regulatory and quality compliance teams involved in global Post-Market Surveillance (PMS) and Medical Device Reporting (MDR) for insulin delivery systems and similar class III or high-risk devices.
This report highlights the complexities of global adverse event reporting, specifically how manufacturers manage malfunctions for products produced at international sites but linked to U.S. registration via specific reporting variances. The inability to draw a conclusion due to the lack of returned product underscores a common challenge in root cause analysis for electronic medical devices.
Ensure internal complaint handling procedures account for cross-site reporting variances. Maintain rigorous documentation for incidents where hardware cannot be recovered for analysis, and monitor for trends in similar devices marketed across different global regions.
Event type: Malfunction. Device: PUMP 1886 780G OUS BLE PUMP MG/DL 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF
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