MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-551NAS
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit received with rf pic failed selftest alarm during self test due to a faulty y1 on the rf board.(b)(4).
Event or Problem Description
The customer reported via phone that the insulin pump error alarm.No harm was reported during the incident.Troubleshooting was performed.The insulin pump was returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551NAS
• 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: 9914764
• Report Number: 3004209178-2020-93066
• Device Sequence Number: 13625819
• Product Code: OZO
• UDI-Device Identifier: 00643169736054
• UDI-Public: (01)00643169736054
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-551NAS
• Device Catalogue Number: MMT-551NAS
• Device Lot Number: A6551NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 145