MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723RNAP
Health Effect - Clinical Codes	Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	10/15/2017
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.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 spouse reported via phone call the insulin pump alarmed motor error.The customer¿s blood glucose level was in the 400 mg/dl at the time of the incident.The customer¿s spouse stated that the insulin pump.The customer¿s parent stated that the drive support cap was normal and that the insulin pump was not exposed to high magnetic fields.Customer reported to have received a motor position encoder error.Customer's spouse also reported customer had experienced a high blood glucose of over 400 mg/dl and treated with manual injection.Declined high blood glucose troubleshooting.The customer¿s parent was advised to have customer discontinue use of the insulin pump and to revert to the back-up plan.The insulin pump is being replaced and is expected to return for analysis.
Additional Manufacturer Narrative
Unit passed displacement test, basic occlusion test and prime/compromised force sensor system test.However, unit was received with stuck in motor error alarm loop during bolus delivery and motor position encoder error alarm confirmed in history file.The motor was tested outside of the device and passed.The motor may have had an intermittent failure that was not detected during our testing.Unit was received with minor scratched display window, cracked case at display window corner, cracked battery tube threads and cracked reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAP
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 6972330
• Report Number: 2032227-2017-60646
• Device Sequence Number: 19139544
• Product Code: OYC
• UDI-Device Identifier: 00613994904393
• UDI-Public: (01)00613994904393
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-723RNAP
• Device Catalogue Number: MMT-723RNAP
• Device Lot Number: A000204715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Initial Date Received by Manufacturer: 10/15/2017
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 02/28/2018
• 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
• Patient Age: 80 YR
• Patient Weight: 144