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

Model Number	MMT-722NAP
Medical Device Problem Codes	Mechanical Problem (1384); Battery Problem (2885); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.
Event or Problem Description
The customer reported via phone call that the insulin pump had motor errors more than once.The customer¿s blood glucose was unknown at the time of incident.The customer also state that insulin pump had rejected new battery and hairline fracture where the reservoir goes and also state that reservoir had been loose but never fallen out.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device received with all operating currents within spec and passed self-test, a21 error test and displacement test.No unexpected low battery, weak battery, battery out limit or failed battery test alarms noted during testing.However, device alarmed motor error during basic occlusion test due to faulty force sensor resistor.Unable to perform basic occlusion test, occlusion test, prime or a33 test, excessive no delivery test due to motor error alarm.However, device passed rewind test and displacement test.Motor passed motor test.Device had broken reservoir tube lip.The test reservoir locked in place properly and no anomaly noted.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAP
• 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: 8573034
• Report Number: 3004209178-2019-91948
• Device Sequence Number: 2494872
• Product Code: OYC
• UDI-Device Identifier: 00613994402028
• UDI-Public: (01)00613994402028
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/16/2019

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-722NAP
• Device Catalogue Number: MMT-722NAP
• Device Lot Number: A5722NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 103