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

Model Number	MMT-523NAP
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	05/07/2017
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.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 phone call that they woke up to a high blood glucose level of 510 mg/dl.The customer stated the infusion set¿s needle was bent.The customer¿s current blood glucose level was 489 mg/dl.The customer declined troubleshooting for the high blood glucose.The customer stated that they ate and their blood glucose level was starting to go up.The new infusion set was also giving her a no delivery alarm.Troubleshooting was performed and insulin exited without incident.The cannula was not bent.The infusion sets will be replaced.The device will not be returned for analysis.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAP
• 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: 6613056
• Report Number: 3004209178-2017-52334
• Device Sequence Number: 13669769
• Product Code: OYC
• UDI-Device Identifier: 00643169077676
• UDI-Public: (01)00643169077676
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

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-523NAP
• Device Catalogue Number: MMT-523NAP
• Device Lot Number: A6523NAPJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2017
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 125