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	Premature Discharge of Battery (1057); Loss of Data (2903)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit passed self-test, a21 error test and displacement test.No unexpected a17 alarm, a21 alarm or reset time/date anomaly after change battery noted during testing.However, unit received a33 alarm during the basic occlusion test due to loose/protruded drive support disk.Unable to perform basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test due to a33 alarm.(b)(4).
Event or Problem Description
Information received by medtronic indicated that the insulin pump had no delivery alarm.No harm requiring medical intervention was reported.The customer stated that fixed prime or fill cannula of 5 unit was performed and insulin exited.The insulin pump will be returned for analysis.

• 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; * 00777-3869
• MDR Report Key: 9915276
• Report Number: 3004209178-2020-93257
• Device Sequence Number: 13641974
• Product Code: OYC
• UDI-Device Identifier: 00613994622563
• UDI-Public: (01)00613994622563
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2020

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-722NAP
• Device Catalogue Number: MMT-722NAP
• Device Lot Number: A7722NAPJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1