MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-722NAS
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 the insulin pump alarmed compromised force sensor system and a motor error.The customer¿s blood glucose level was unknown at the time of the incident.The customer stated that the insulin pump alarmed compromised force sensor system during priming process and a motor error alarm during rewind.The customer stated that the drive support cap was protruded.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.
Additional Manufacturer Narrative
Pump received with loose/protruded drive support disk, minor scratched display window, cracked case at display window corners, cracked battery tube threads and cracked reservoir tube lip.Pump unable to prime during prime test and motor error alarm during basic occlusion test due to loose/protruded drive support disk.No compromised force sensor system alarm noted.Pump passed displacement test.Unable to perform occlusion test and excessive no delivery test due to prime anomaly.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS
• 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: 7031585
• Report Number: 2032227-2017-65808
• Device Sequence Number: 1132320
• Product Code: OYC
• UDI-Device Identifier: 00613994271402
• UDI-Public: (01)00613994271402
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 03/13/2018

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-722NAS
• Device Catalogue Number: MMT-722NAS
• Device Lot Number: A2722NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 11/03/2017
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 265