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

Model Number	MMT-751LNAB
Medical Device Problem Codes	Obstruction of Flow (2423); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The insulin pump received with complete broken reservoir tube lip.Unable to perform basic occlusion test and occlusion test due to broken reservoir tube lip.However, insulin pump was received with normal operating currents and passed self-test, rewind test, displacement test, prime, compromised force sensor system test and excessive no delivery test.No unexpected low battery alarm anomalies noted.Pump received with broken reservoir tube lip, missing reservoir tube o ring, cracked case at the display window corners, cracked lcd window, stained end cap sticker, stained address, serial number label and cracked reservoir tube lip.The test infusion set and reservoir does not lock into place.
Event or Problem Description
Information received by medtronic stated that the insulin pump had unexplained no delivery alarms and the battery occasionally lasts less than a week.No harm was required during medical intervention.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-751LNAB
• 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: 11326804
• Report Number: 2032227-2021-114599
• Device Sequence Number: 16322420
• Product Code: OZO
• UDI-Device Identifier: 00643169507746
• UDI-Public: (01)00643169507746
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 02/15/2021

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-751LNAB
• Device Catalogue Number: MMT-751LNAB
• Device Lot Number: A4751LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 70