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

Model Number	MMT-523LNAB
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	11/07/2018
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
It was reported via phone call that the customer's insulin pump failed several times since (b)(6) 2018 with blood glucose of 49 mg/dl at the time of the incident.The customer received emergency medical assistance for the low.The caller did not mention how the customer was treated.The caller did not mention any symptoms.The customer was wearing the insulin pump during the incidents but had taken it off at some point.Troubleshooting was not completed as the caller declined.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device received with operating currents within spec.Device passed displacement test, self test and unexpected restart error test.Device alarmed compromised forced sensor system during basic occlusion test due to loose / flush drive support disk.Unable to perform prime test, excessive no delivery test, delivery accuracy test and occlusion test due to compromised forced sensor system alarms.Device received with cracked case at display window corners, display window, reservoir tube lip and battery tube threads.Device received with minor scratched display window and case.Device received with stained end cap sticker and back address serial number label.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAB
• 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: 8092891
• Report Number: 2032227-2018-63716
• Device Sequence Number: 16483542
• Product Code: OYC
• UDI-Device Identifier: 00643169151277
• UDI-Public: (01)00643169151277
• 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): 04/03/2019

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-523LNAB
• Device Catalogue Number: MMT-523LNAB
• Device Lot Number: A2523LNABJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 99