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
Medical Device Problem Codes	Failure to Cycle (1142); Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Priming Problem (4040)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2019
Type of Reportable Event	Malfunction
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 reported via phone call that the insulin pump had a compromised forced sensor system error.The customer's blood glucose level was 159 mg/dl.The customer reported that the insulin was squirting out during manual priming.The customer mentioned that the battery cap had a crack on the top and she used to glue it back and used it for a month.Customer stated they were unable to exit the preparing to prime loop.Customer stated they are stuck in rewind complete and bolus delivery loop.They stated that the drive support cap was protruded.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
Insulin pump passed the displacement test.Device received with motor error alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform prime test, excessive no delivery test and occlusion test or verify a33 alarm and prime/fill anomalies due to motor error alarm.Insulin pump received with loose drive support disk and stripped battery cap coin slot(p).

• 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: 9143923
• Report Number: 2032227-2019-72081
• Device Sequence Number: 2837839
• Product Code: OYC
• UDI-Device Identifier: 00643169221499
• UDI-Public: (01)00643169221499
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: A000290378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: 09/28/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR