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

Model Number	MMT-723RNAL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2017
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 they received a compromised force sensor system alarm during the fill tubing process.Customer's blood glucose was 131 mg/dl.Troubleshooting found the customer's drive support cap was flush.Customer could not recall pressing on the cap while connected.The customer was advised to disconnect from the insulin pump and revert to a back-up plan.The customer was advised that the device would be replaced.Customer agreed to return the product for analysis.
Additional Manufacturer Narrative
Insulin pump passed the displacement test.Unit was received with motor error alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform prime/compromised force sensor system test, excessive no delivery test and occlusion test or verify compromised force sensor system alarm due to motor error alarm.Insulin pump was received with minor scratched lcd window, cracked belt clip slot, cracked battery tube threads, missing end cap sticker, stained address/serial number label and cracked reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAL
• 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: 6946913
• Report Number: 2032227-2017-58354
• Device Sequence Number: 1141180
• Product Code: OYC
• UDI-Device Identifier: 00613994748737
• UDI-Public: (01)00613994748737
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2018

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-723RNAL
• Device Catalogue Number: MMT-723RNAL
• Device Lot Number: A000168688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Initial Date Received by Manufacturer: 10/08/2017
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 10/12/2017
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 254