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

Model Number	MMT-723RNAB
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2017
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 the insulin pump alarmed unexpected restart and external ram error.The customer¿s blood glucose level was unknown at the time of the incident.Customer reported that pump was not stored or not in use for an extended period of time.After troubleshooting for unexpected restart alarm, customer was advised the reservoir will be replaced.Customer declined troubleshooting for external ram error alarm.The insulin pump will be returned for analysis.
Additional Manufacturer Narrative
The device was received with all operating currents within specification and passed functional testing including the rewind test, unexpected restart error test, basic occlusion test, occlusion test, prime test, excessive no delivery test and displacement test.No unexpected alarms anomalies noted.The insulin pump was received with minor scratched lcd window, cracked case at the display window corners, cracked belt clip slot, cracked battery tube threads, stained end cap sticker, stained address, serial number label and cracked reservoir tube lip.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723RNAB
• 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: 6885167
• Report Number: 2032227-2017-51489
• Device Sequence Number: 16302012
• Product Code: OYC
• UDI-Device Identifier: 00613994748713
• UDI-Public: (01)00613994748713
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 01/25/2018

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-723RNAB
• Device Catalogue Number: MMT-723RNAB
• Device Lot Number: A000167986
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 148