MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-751NAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-751NAS
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	05/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 our knowledge.
Event or Problem Description
Customer reported via phone call that they experienced high blood glucose.The customer blood glucose level was 500 mg/dl at the time of incident.Customer reported that the other blood glucose values were 178 mg/dl, 190 mg/dl and 200 mg/dl.Customer reported that they allege insulin pump was under delivering.Customer was using insulin pump system within 48 hours of reported high blood glucose event.Customer was neither in emergency room, nor admitted into hospital, nor was emergency medical service dispatched as a result of high blood glucose.Customer treated with bolus.Customer performed displacement test and test was passed.Customer reported that reservoir had air bubbles.Customer reported that small bubbles into a large one then slowly push on the plunger of the reservoir to remove air bubbles.Air bubbles were successfully removed.The customer was assisted with troubleshooting and declined for high blood glucose.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAS
• Common Device Name: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• MDR Report Key: 10094858
• Report Number: 2032227-2020-123049
• Device Sequence Number: 14337691
• Product Code: OZO
• UDI-Device Identifier: 00643169736108
• UDI-Public: (01)00643169736108
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751NAS
• Device Catalogue Number: MMT-751NAS
• Device Lot Number: A6751NASJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2020
• Initial Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-MMT-332A-RSVR, UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Weight: 64