MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723RNAS
Medical Device Problem Code	Priming Problem (4040)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	06/10/2019
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.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 wife reported via phone call that her husband was hospitalized due to high blood glucose and diabetic ketoacidosis.Blood glucose was unknown.Customer also reported that insulin pump had rewind anomaly and they were unable to exit the preparing to prime loop and troubleshooting was performed.Customer stated they did not receive 2nd series of beeps nor did numbers appear on the screen.The customer declined troubleshoot for high blood glucose.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 test, excessive no delivery test and delivery accuracy test.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.After completing the rewind test, installed in the reservoir compartment.Device recognized the water filled reservoir that was installed in the reservoir compartment.Then the unit was programmed with a 2.0 unit fill cannula delivery.The unit delivered the 2.0 units properly with water exiting the infusion set.No rewind anomaly or prime/fill anomaly noted during testing.Device uploaded properly using care link.Device had minor scratched display window.(b)(4).

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAS
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 8729921
• Report Number: 2032227-2019-20649
• Device Sequence Number: 16649600
• Product Code: OYC
• UDI-Device Identifier: 00643169693937
• UDI-Public: (01)00643169693937
• Combination Product (Y/N): N
• 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): 07/16/2019

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-723RNAS
• Device Catalogue Number: MMT-723RNAS
• Device Lot Number: A2723RNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/16/2019
• 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 SET
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 75 YR
• Patient Weight: 73