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	Mechanical Problem (1384); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information that provided with the initial report was incorrect.The correct information has been included with this report in.(b)(4).
Event or Problem Description
It was reported that the insulin pump had damage near the battery and reservoir compartment, frequent unexplained no delivery alarms.There was no damage to the reservoir lip ring.
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 reported via phone call the insulin pump had motor error alarm.Customer blood glucose at the time of incident was 64 mg/dl.Troubleshooting was not performed.The insulin pump will not be returning 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
• MDR Report Key: 10022768
• Report Number: 2032227-2020-112732
• Device Sequence Number: 14078917
• Product Code: OZO
• UDI-Device Identifier: 00643169933187
• UDI-Public: (01)00643169933187
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/12/2020

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?: No
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 240