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

Model Number	MMT-751NAP
Medical Device Problem Codes	Failure to Cycle (1142); Mechanical Problem (1384); Battery Problem (2885); Patient Device Interaction Problem (4001); Priming Problem (4040)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
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
The customer reported via phone call that the insulin pump shoot insulin out from cannula and loosing more than 2 to 3 drops during prime.The customer's blood glucose value was unknown.The customer reported chipped around battery housing, batteries lasting less than 7 days, insulin pump taking longer to prime and motor getting louder.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device was received with the operating currents within spec.And passed the self test, a21 error test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test, displacement test, and the delivery accuracy test.A test p-cap and reservoir does lock into place inside the reservoir compartment properly.Device primed properly and no a33 alarm, unusual motor noise, or battery related errors occurred during testing.Device was received with minor scratched lcd window and scratched reservoir tube window.No damage to the battery tube or battery tube threads noted during visual inspection.

• Brand Name: 530G INSULIN PUMP MMT-751NAP
• 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: 9196238
• Report Number: 2032227-2019-104592
• Device Sequence Number: 14239652
• Product Code: OZO
• UDI-Device Identifier: 00643169736092
• UDI-Public: (01)00643169736092
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/24/2020

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-751NAP
• Device Catalogue Number: MMT-751NAP
• Device Lot Number: A6751NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Received by Manufacturer: 10/12/2019
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR