MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAP
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	05/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 that they were hospitalized due to high blood glucose and diabetic ketoacidosis on (b)(6) 2019.The customer's blood glucose was 573 mg/dl.Customer has been using insulin pump system within 48 hours of reported high blood glucose event.The customer treated high blood glucose with manual injection.The customer stated they gave bolus to themselves but blood glucose was not going down.Based on customer report customer did allege pump was under delivering.The drive support cap appears normal.The customer did not report air bubbles and leak in both reservoir and tubing.Customer was unable to complete carelink upload.The insulin pump will not 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 at 0.08735 inches.No under delivery anomaly or over delivery anomaly noted.The stop current and run current measurement tests are within specification.Device also passed self test, off no power alarm test the no delivery alarm functions properly during the basic occlusion test and occlusion test.No unexpected no delivery alarm noted.Device uploaded properly using carelink.Device had minor scratched display window and cracked battery tube threads.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAP
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 8643633
• Report Number: 2032227-2019-07226
• Device Sequence Number: 2319232
• Product Code: OYC
• UDI-Device Identifier: 00643169221543
• UDI-Public: (01)00643169221543
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/26/2019

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-523RNAP
• Device Catalogue Number: MMT-523RNAP
• Device Lot Number: A000207238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 05/27/2019
• Supplement Report FDA Received Date: 06/26/2019
• 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: 76 YR
• Patient Weight: 66