MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523NAH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hyperglycemia (1905)
Date of Event	07/04/2020
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.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
Customer reported via phone call that they experienced high blood glucose.The customer blood glucose level were 492 mg/dl and 488 mg/dl at the time of incident and current blood glucose value was 159 mg/dl.Customer was using insulin pump system within 48 hours of reported high blood glucose event.Customer was neither in emergency room, nor admitted into hospital, nor was emergency medical service dispatched as a result of high blood glucose.Customer reported that the drive support cap was normal.Customer had abdominal pain.Customer treated with intravenous insulin drip.The customer was assisted with troubleshooting and declined for high blood glucose.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test but failed during the basic occlusion test due to protruded drive support disk.Unable to perform the occlusion, prime or a33 and excessive no delivery test due to loose drive support disk noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAH
• 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: 10249717
• Report Number: 2032227-2020-144026
• Device Sequence Number: 2853463
• Product Code: OYC
• UDI-Device Identifier: 00643169507173
• UDI-Public: (01)00643169507173
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/07/2020

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-523NAH
• Device Catalogue Number: MMT-523NAH
• Device Lot Number: B4523NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: 07/05/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/07/2020
• 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-RSVR, UNOMED SET¿
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Weight: 56