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

Model Number	MMT-751RNAS
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	10/22/2017
Type of Reportable Event	Serious Injury
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.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
The customer reported via phone call for low blood glucose.The customer¿s blood glucose was 50 mg/dl at the time of the incident.Patient's current bg: 599 mg/dl.Customer treated with a glucagon shot.Customer reported that his insulin pump is not acting right.Customer stated all of a sudden all the alarms came up.Customer went low and was chewing on a pint glass and now his teeth are busted up.Patient has been experiencing low bgs for a couple of weeks.The drive support cap appears normal (slightly indented).Customer stated the pump screen is all scratched up and has a crack at battery cap area.The pump will be returned for analysis.
Additional Manufacturer Narrative
A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.Unit was received with normal operating currents and passed self-test, unexpected restart error test.No unexpected off no power, low battery, battery out limit and failed battery test alarms during testing.Also, unit passed rewind test, basic occlusion test, occlusion test, prime/compromised force sensor system test, excessive no delivery test and displacement test.Unit was programmed with test minilink and the glucose sensor simulator.Unit communicated properly with glucose sensor simulator.The low predicted alert and the high sensor glucose alert properly no anomaly noted.Unit had minor scratched lcd window, cracked battery tube threads, cracked reservoir tube lip, cracked belt clip slot, stained address/serial number label and stained end cap sticker.

• Brand Name: 530G INSULIN PUMP MMT-751RNAS
• 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: 6982444
• Report Number: 2032227-2017-62193
• Device Sequence Number: 16254440
• Product Code: OZO
• UDI-Device Identifier: 00643169508002
• UDI-Public: (01)00643169508002
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-751RNAS
• Device Catalogue Number: MMT-751RNAS
• Device Lot Number: A3751RNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Initial Date Received by Manufacturer: 10/22/2017
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR