MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-723NAH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pump passed the displacement test.Unit received with motor error alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform the unexpected restart error test, prime/compromised force sensor system test, excessive no delivery test and occlusion test or verify unexpected restart alarm due to motor error alarm.The test infusion set and reservoir does lock into place.Pump received with minor scratched lcd window, cracked case at the display window corners, cracked lcd window, cracked belt clip slot, cracked battery tube threads, stained end cap sticker, stained address/serial number label and broken reservoir tube lip.
Event or Problem Description
The customer reported via phone call the insulin pump alarmed motor error and power error and low battery alerts.The customer¿s blood glucose level was 300mg/dl at the time of the incident.The customer stated that the drive support cap was normal and that the insulin pump was not exposed to high magnetic fields and was able to complete the rewind process.The customer was advised to 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.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723NAH
• Common Device Name: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 7510184
• Report Number: 3004209178-2018-71371
• Device Sequence Number: 2687381
• Product Code: OYC
• UDI-Device Identifier: 00643169077706
• UDI-Public: (01)00643169077706
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 05/14/2018

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-723NAH
• Device Catalogue Number: MMT-723NAH
• Device Lot Number: A7723NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 177