MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522NAS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/13/2020
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.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 call that the customer had high blood glucose level of 535 mg/dl.Customer had blood glucose levels of 478, 409, 346, 435 and 443 mg/dl.Customer was treated with manual injection.Customer was using auto mode.Customer did not allege insulin pump for under delivery.Customer stated that there was no air bubbles and leak.Customer did high pressure test and it was passed.Customer was using insulin pump system within 48 hours of reported high blood glucose level event.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test.Device received with motor error alarm during the basic occlusion test due to loose/flush drive support disk.Unable to perform prime/a33 test, excessive no delivery test and occlusion test due to motor error alarm.(b)(4).

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAS
• 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: 9974875
• Report Number: 2032227-2020-105719
• Device Sequence Number: 14151740
• Product Code: OYC
• UDI-Device Identifier: 00613994402097
• UDI-Public: (01)00613994402097
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/26/2020

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-522NAS
• Device Catalogue Number: MMT-522NAS
• Device Lot Number: A5522NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 06/26/2020
• 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-MMT-326A, UNOMED MMT-397
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Weight: 130