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

Model Number	MMT-523NAL
Medical Device Problem Codes	Failure to Cycle (1142); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	01/21/2020
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
The customer¿s daughter reported via phone call that they were hospitalized due to high blood glucose and diabetic ketoacidosis on (b)(6) 2020 with blood glucose level was above 500 mg/dl.Customer also stated that the insulin pump had compromised force sensor system alarm.Customer stated that drive support cap was normal.The customer was assisted with troubleshooting.The customer was in hospital and did not have any sets or reservoirs with them.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The information that provided with the initial report was incorrect.The correct information has been included with this report.
Event or Problem Description
It was reported by customer¿s daughter via phone call that they were hospitalized on (b)(6) 2020 due to high blood glucose and diabetic ketoacidosis.Blood glucose level was 500 mg/dl at the time of admission.Customer was treated with insulin drip while in the emergency room.Customer also reported that the insulin pump had compromised force sensor system alarm.Customer stated that the drive support cap was normal.The customer was still in the hospital at the time of the call and could not troubleshoot due to the alarm.The insulin pump will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523NAL
• 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: 9645439
• Report Number: 3004209178-2020-61657
• Device Sequence Number: 11624487
• Product Code: OYC
• UDI-Device Identifier: 00643169202320
• UDI-Public: (01)00643169202320
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 02/03/2020

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-523NAL
• Device Catalogue Number: MMT-523NAL
• Device Lot Number: A9523NALJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/04/2020
• 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-326-RSVR, UNOMED SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Weight: 82