MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-523RNAH
Medical Device Problem Codes	Obstruction of Flow (2423); Priming Problem (4040)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	03/30/2020
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.(b)(4).
Event or Problem Description
Customer reported via phone call high blood glucose levels, no delivery alarm and prime fill anomaly on the insulin pump.Customer's blood glucose level was 400 mg/dl.Customer treated their high blood glucose levels via insulin pump.Customer's blood glucose went down to 66 mg/dl.Troubleshooting was performed.Customer advised insulin squirted out during the changing of their tubing and reservoir.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Device passed displacement test.Basic occlusion test.Device failed prime or a33 test at 2.5 lbs due to faulty force sensor resistor.Unable to perform occlusion test and excessive no delivery test or verify no delivery alarm.Device programmed with the current time and date and monitored for several days.The time and date is functioning properly.No a21 alarm noted.No unexpected device or history reset noted during testing.Device was programmed with multiple test boluses and monitored.All boluses delivered properly and was listed in the bolus history screen.No bolus anomaly or bolus history anomaly noted.
Additional Manufacturer Narrative
Device passed displacement test.Basic occlusion test.Device failed prime/a33 test at 2.5lbs due to faulty force sensor resistor.Unable to perform occlusion test and excessive no delivery test or verify no delivery alarm.Device programmed with the current time and date and monitored for several days.The time and date is functioning properly.No a21 alarm noted.No unexpected device or history reset noted during testing.Device was programmed with multiple test boluses and monitored.All boluses delivered properly and was listed in the bolus history screen.No bolus anomaly or bolus history anomaly noted.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAH
• 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: 9936904
• Report Number: 2032227-2020-102228
• Device Sequence Number: 2718215
• Product Code: OYC
• UDI-Device Identifier: 00643169221529
• UDI-Public: (01)00643169221529
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 07/08/2020

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-523RNAH
• Device Catalogue Number: MMT-523RNAH
• Device Lot Number: A000300038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/26/2020; 07/08/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/29/2020; 07/09/2020
• 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: 54 YR
• Patient Weight: 150