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

Model Number	MMT-722NAL
Medical Device Problem Codes	Obstruction of Flow (2423); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unit received with scratched case, minor scratched lcd window, cracked reservoir tube lip, cracked lcd window and cracked case at the display window corner.Unit received with no button response due to flattened (escape, act and up) button dome switch (no crease) and partial unlocked j2/lcd keypad connector noted during visual inspect.Unable to verify excessive no delivery alarm and perform displacement test, basic occlusion test, occlusion test, prime or compromised forced sensor system test, rewind test and excessive no delivery test due to no button response.
Event or Problem Description
Customer reported via phone call that the insulin pump had several issues.Customer¿s blood glucose was unknown at the time of incident.Customer reported that the insulin pump had a no delivery alarm, scratches on the body of the insulin pump, cracks on the reservoir compartment.Customer declined troubleshooting.Insulin pump is not expected to return for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NALL
• 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: 8369049
• Report Number: 3004209178-2019-59545
• Device Sequence Number: 16408452
• Product Code: OYC
• UDI-Device Identifier: 00613994402035
• UDI-Public: (01)00613994402035
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 02/25/2019

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-722NAL
• Device Catalogue Number: MMT-722NAL
• Device Lot Number: A5722NALJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 179