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

Model Number	MMT-723NAL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	01/11/2018
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
Customer reported via phone call that they experienced high blood glucose level of 418 mg/dl and that the insulin pump was alarming no delivery.The customer reported that they had received a replacement pump due to excessive no delivery alarms and believes the issue to be related to the infusion sets.Customer declined to troubleshoot for high readings.The customer did not have an additional infusion set available to perform troubleshooting.Customer was advised to change the infusion set, reservoir and insulin and to treat per healthcare professional's recommendation.The product was not returned for analysis.
Additional Manufacturer Narrative
Insulin pump passed displacement test, rewind test, basic occlusion test, prime test, excessive no delivery test and occlusion test.No excessive no delivery alarms noted.(b)(4).
Event or Problem Description
The initial report and or supplemental report had the incorrect incident date.The correct incident date is (b)(6) 2017.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAL
• 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: 7830869
• Report Number: 2032227-2018-20659
• Device Sequence Number: 1188755
• Product Code: OYC
• UDI-Device Identifier: 00643169693791
• UDI-Public: (01)00643169693791
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 10/24/2019

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-723NAL
• Device Catalogue Number: MMT-723NAL
• Device Lot Number: B6723NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 10/25/2019
• 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: Other
• Patient Age: 31 YR
• Patient Weight: 250