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); Moisture or Humidity Problem (2986); Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(b)(4).Unit power up properly after battery installation.Unit received with operating currents within spec.No unexpected battery alarms including failed battery test alarms were noted.Unit passed self test, basic occlusion test and displacement test.Unable to prime unit during prime/a33 test due to faulty fsr (gold).Unable to perform occlusion test or excessive no delivery test due to prime anomaly.No traces of moisture were noted at the electronic or motor assemblies per visual inspection.
Event or Problem Description
Information received by medtronic indicated that the insulin pump had rejected battery, moisture in the screen, unexplained no delivery alarms.Customer declined for troubleshooting.No harm requiring medical intervention was reported.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: 9942135
• Report Number: 3004209178-2020-96745
• Device Sequence Number: 5555886
• Product Code: OZO
• UDI-Device Identifier: 00643169933187
• UDI-Public: (01)00643169933187
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 04/08/2020

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-751LNAB
• Device Catalogue Number: MMT-751LNAB
• Device Lot Number: A5751LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 149