MAUDE Adverse Event Report: MEDTRONIC MINIMED 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	Date/Time-Related Software Problem (2582); Patient Device Interaction Problem (4001); Priming Problem (4040)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2018
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 the reset date and time on insulin pump every time she changes battery.The customer¿s blood glucose was unknown at the time of the incident.Insulin pump was making strange noise when priming after replacing.The insulin pump will not be returned for analysis.
Additional Manufacturer Narrative
Device passed the displacement test, rewind, basic occlusion, occlusion, prime/a33 and excessive no delivery test.Device primed properly.No frozen screen noted during test and time clock advances properly.No unexpected prime noise anomalies noted.Device received with cracked case at the display window corners.

• 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 MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• MDR Report Key: 8193549
• Report Number: 2032227-2018-78413
• Device Sequence Number: 2025110
• Product Code: OYC
• UDI-Device Identifier: 00613994402028
• UDI-Public: (01)00613994402028
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 11/20/2019

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: A000119736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/24/2018
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR