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

Model Number MMT-751LNAS

Device Problem Priming Problem (4040)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sw 3.0d on the event date (b)(6) 2021.Customer returned pump for an alleged pump prime/fill anomaly.Pump passed a21 error test, seat, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test.Pump history download using thds was successful.A47 alarms found on the history file which caused corrupted data.Unable to confirm the reported event date due to the corrupted data.A47 alarms are due to the pump not having power for a long period of time.Test reservoir lock properly inside the reservoir tube.The following were noted during visual inspection: no cosmetic damage found.Not confirmed prime/fill anomaly during testing.Unit passed required testing.

Event Description

Information received by medtronic indicated that the insulin pump was continue to came out during priming.Customer stated that insulin squirting out during the fill tubing process.No harm requiring medical intervention was reported.The customer will discontinue use of the device.

• Brand Name: 530G INSULIN PUMP MMT-751LNAS
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635140379
• MDR Report Key: 13730452
• MDR Text Key: 289965440
• Report Number: 2032227-2022-127857
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000161170
• UDI-Public: (01)000000763000161170
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-751LNAS
• Device Catalogue Number: MMT-751LNAS
• Device Lot Number: A6751LNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Female