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	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Insulin pump passed the displacement test.Unit received with motor error alarm during the basic occlusion test due to loose, protruded drive support disk.Unable to perform prime test, excessive no delivery test and occlusion test or verify motor position encoder error alarm due to motor error alarm.Insulin pump received with cracked belt clip slot, missing end cap sticker, missing address, serial number label and cracked reservoir tube lip.
Event or Problem Description
Information received by medtronic indicated that the insulin pump had motor error alarm.Customer stated that the insulin was leaked inside the insulin pump.Customer stated that the drive support cap was normal.Customer was able to clear the alarm.No harm requiring medical intervention was reported.The insulin pump will be 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: 11901076
• Report Number: 2032227-2021-150654
• Device Sequence Number: 19097284
• Product Code: OZO
• UDI-Device Identifier: 00643169503663
• UDI-Public: (01)00643169503663
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/28/2021

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-551NAS
• Device Catalogue Number: MMT-551NAS
• Device Lot Number: A4551NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 91