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 Codes	Mechanical Problem (1384); Moisture or Humidity Problem (2986); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Insulin pump passed the displacement test and self test.However, moisture damage at electronic assembly.Also, moisture damage motor during visual inspection.No unexpected rewind anomalies noted.Insulin pump received with cracked case, cracked case from display window corner, cracked reservoir tube window, cracked case from reservoir tube window corners and cracked reservoir tube lip.The test infusion set and reservoir does lock into place.(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
Information received by medtronic indicated that insulin pump had casing cracked and concerned of water damage, loud to rewind.No harm requiring medical intervention was reported.The device will not 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: 10519673
• Report Number: 2032227-2020-175497
• Device Sequence Number: 3438191
• Product Code: OZO
• UDI-Device Identifier: 00643169503663
• UDI-Public: (01)00643169503663
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/11/2020

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: A4551NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 87