MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522NAS
Medical Device Problem Codes	Mechanical Problem (1384); Loss of Data (2903); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
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 that the insulin pump had unexpected restart alarm.Customer¿s blood glucose was more than 200 mg/dl at the time of incident.Customer stated that the piston was not stop moving forward until it pushes all the insulin out.Customer stated that the reservoir and battery compartment was cracked.The customer was advised to discontinue use of the pump and revert to backup plan per healthcare professional instructions.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and delivery accuracy test at 0.08750 inches.The stop current and run current measurement tests are within specification.Device also passed self test, off no power alarm test and a21 error test.During the occlusion test, the unit recognized the water filled reservoir that was installed in the reservoir compartment.Device was programmed with a 2.0 unit fill cannula delivery.Then the unit delivered the 2.0 units properly with water exiting the infusion set.No prime anomaly noted.Device powered up properly after the test battery was installed.No display anomaly or back light anomaly noted.No drive/motor anomaly or a17 alarm noted during testing.The motor was tested outside of the unit and passed.Device uploaded properly using carelink.Device had minor scratched display window, cracked display window, cracked case at display window corner, cracked battery tube threads, cracked case at the reservoir tube window corner, cracked reservoir tube window and cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAS
• 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: 9436840
• Report Number: 2032227-2019-129450
• Device Sequence Number: 14481808
• Product Code: OYC
• UDI-Device Identifier: 00613994402097
• UDI-Public: (01)00613994402097
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/30/2020

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-522NAS
• Device Catalogue Number: MMT-522NAS
• Device Lot Number: A5522NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/30/2020
• 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
• Patient Weight: 67