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

Model Number	MMT-751NAB
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384); Obstruction of Flow (2423); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Insulin pump passed the displacement test but rewind anomaly during the basic occlusion test due to loose drive support disk.Unable to perform the occlusion, prime and excessive no delivery alarm due to loose drive support disk.Insulin pump received with cracked battery tube threads, cracked reservoir tube lip, missing end cap sticker and broken battery cap.The p-cap locks into the reservoir compartment properly noted.
Event or Problem Description
Information received by medtronic indicated that the casing of insulin pump was cracked, battery cap damaged.It had different grinding noises, no delivery alarm.No harm requiring medical intervention was reported.The insulin pump was returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751NAB
• 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: 11839792
• Report Number: 2032227-2021-146286
• Device Sequence Number: 3363011
• Product Code: OZO
• UDI-Device Identifier: 00643169503670
• UDI-Public: (01)00643169503670
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/18/2021

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-751NAB
• Device Catalogue Number: MMT-751NAB
• Device Lot Number: A4751NABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 95