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 Codes	Obstruction of Flow (2423); Battery Problem (2885); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).No button error alarm noted.Insulin pump had unresponsive buttons due to flattened esc and act buttons dome switch.No unlocked lcd keypad connector noted.Unable to perform operating currents, self-test, unexpected restart alarm error test, rewind test, basic occlusion test, occlusion test, prime, compromised force sensor test, excessive no delivery test and displacement test or verify low battery, no delivery alarm due to unresponsive button.Insulin pump had minor scratched lcd window, no cracked lcd window noted.The test reservoir locked in place properly and no anomaly noted.
Event or Problem Description
Information received by medtronic indicated that the insulin pump had a scratches on the screen.The customer stated that the insulin pump rejected more batteries.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: 10738954
• Report Number: 2032227-2020-196695
• Device Sequence Number: 3060744
• Product Code: OZO
• UDI-Device Identifier: 00643169503717
• UDI-Public: (01)00643169503717
• 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): 10/27/2020

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-751NAS
• Device Catalogue Number: MMT-751NAS
• Device Lot Number: A4751NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 79