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
Medical Device Problem Codes	Mechanical Problem (1384); Device Difficult to Program or Calibrate (1496); Obstruction of Flow (2423); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2019
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
Customer reported via phone call that the insulin pump buttons were less responsive, had to press multiple times.The customer¿s blood glucose level was unknown at the time of the incident.Customer stated insulin pump had cracked where reservoir goes in from tip to glass on both sides, rewind takes a little longer, received unexplained no delivery alerts, changes out set completely.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device had unresponsive up and down buttons due to corroded keypad traces.Unable to perform self-test, rewind test, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and displacement test or verify no delivery alarm, rewind anomaly due to unresponsive button.Device had cracked reservoir tube window, cracked case at reservoir tube window corners.The reservoir tube lip was partially broken off but the test reservoir locked in place.(b)(4).

• 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: 9333608
• Report Number: 2032227-2019-118785
• Device Sequence Number: 1927231
• Product Code: OYC
• UDI-Device Identifier: 00613994373083
• UDI-Public: (01)00613994373083
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/23/2020

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-722NAS
• Device Catalogue Number: MMT-722NAS
• Device Lot Number: A4722NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/17/2019
• Supplement Report FDA Received Date: 10/23/2020
• 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: 150