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

Model Number	MMT-551LNAL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Vomiting (2144); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	04/12/2020
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¿s son reported via phone call that customer was hospitalized due to diabetic ketoacidosis and high blood glucose on april 12 to (b)(6) 2020 with blood glucose of 400 mg/dl.Customer was using insulin pump system within 48 hours of reported high blood glucose event.Customer treated with insulin pump.Customer stated they contact their health care professional regarding high blood glucose.Based on customer report customer did not allege insulin pump was under delivering.Customer experienced symptoms such as vomiting.Customer performed high pressure test and test pass.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and delivery accuracy test at 0.08750 inches.The stop current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and a21 error test.The no delivery alarm functions properly during the basic occlusion test and occlusion test.No unexpected no delivery alarm noted during testing.Device uploaded properly using care link.Device had cracked battery tube threads and cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.This mdr related to the (b)(4) manufacturing site has been assigned a medwatch number from the medtronic minimed (b)(4) site, per variance 5.

• Brand Name: 530G INSULIN PUMP MMT-551LNAL
• 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: 9985061
• Report Number: 2032227-2020-107741
• Device Sequence Number: 4483395
• Product Code: OZO
• UDI-Device Identifier: 00643169933019
• UDI-Public: (01)00643169933019
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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 Model Number: MMT-551LNAL
• Device Catalogue Number: MMT-551LNAL
• Device Lot Number: A5551LNALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2020
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 05/11/2020
• 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: Hospitalization
• Patient Age: 9 YR
• Patient Weight: 18