MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722NAS
Medical Device Problem Codes	Failure to Cycle (1142); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
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
Information received by medtronic indicated that the insulin pump had compromised force sensor system.Customer stated that the insulin was squirting out during the manual prime process customer reported that the drive support cap was sticking out.Customer had experienced high blood glucose level of 316 mg/dl and treated it with manual shots.The device will be returned for analysis.
Additional Manufacturer Narrative
Device passed displacement test.However, device alarmed a33 during basic occlusion test due to loose/protruded drive support disk noted.Unable to perform prime/a33 test, occlusion test or excessive no delivery test due to a33 alarms.(b)(4).

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS
• 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: 9990452
• Report Number: 2032227-2020-108908
• Device Sequence Number: 17068633
• Product Code: OYC
• UDI-Device Identifier: 00613994312587
• UDI-Public: (01)00613994312587
• 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): 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-722NAS
• Device Catalogue Number: MMT-722NAS
• Device Lot Number: A3722NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 07/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 112