MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. KIT MMT-1755KR 630G 3ML V4.10 EN RECERT; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number	MMT-1755KR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	12/07/2019
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.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 customer experience hyperglycemia and thirsty.The customer¿s blood glucose level was 517 mg/dl, 493 mg/dl and 159 mg/dl at time of incident.Customer reported that they did not feel okay to troubleshooting.Customer stated that they delivered correction insulin bolus but blood glucose still getting high.The devices will not be returned for analysis.
Additional Manufacturer Narrative
Device passed displacement test, rewind test, prime or seating test, basic occlusion test, force sensor test, selftest and occlusion test.Device was monitored and functioning properly.(b)(4).

• Brand Name: KIT MMT-1755KR 630G 3ML V4.10 EN RECERT
• 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: 9457586
• Report Number: 2032227-2019-131618
• Device Sequence Number: 14229015
• Product Code: OZO
• UDI-Device Identifier: 00763000179632
• UDI-Public: (01)00763000179632(17)220716
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/13/2020

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 Expiration Date: 07/16/2022
• Device Model Number: MMT-1755KR
• Device Catalogue Number: MMT-1755KR
• Device Lot Number: HG3LGDJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: 12/07/2019
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVR, UNOMED INF SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Weight: 74