MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551PNAS; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-551PNAS
Medical Device Problem Codes	Obstruction of Flow (2423); Date/Time-Related Software Problem (2582); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Customer the reported via phone call that the insulin pump¿s clock running slow also no delivery alarm during priming process.Customer's blood glucose level was unknown at the time of the incident.The customer stated that the transmitter declined battery life.The device will not be returned for analysis.
Additional Manufacturer Narrative
The pump passed the self test, rewind test, basic occlusion test, occlusion test, prime, excessive no delivery and displacement tests.No unexpected no delivery alarm was noted during testing.Also, the unit was programmed with the correct time/clock and monitored for seven days with no time/clock anomaly noted during testing.The pump had minor scratches on the lcd window.The reservoir tube lip was tested with the test reservoir locked in place properly and no anomaly was noted.

• Brand Name: 530G INSULIN PUMP MMT-551PNAS
• 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
• MDR Report Key: 8770418
• Report Number: 2032227-2019-26951
• Device Sequence Number: 11189533
• Product Code: OZO
• UDI-Device Identifier: 00643169507302
• UDI-Public: (01)00643169507302
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 03/30/2020

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-551PNAS
• Device Catalogue Number: MMT-551PNAS
• Device Lot Number: A3551PNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Initial Date Received by Manufacturer: 06/29/2019
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 135