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 Code	Device Alarm System (1012)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A test p-cap and reservoir locks into place inside the reservoir compartment properly.The pump was received with the operating currents within spec and passed the functional testing including self test, a21 error test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test, displacement test, and the dat test at 0.08765 inches.Several a47 alarms was found in the pump history file.A47 alarms due to corrupted history file.
Event or Problem Description
Information received by medtronic indicated that insulin pump had absence of no delivery.No harm requiring medical intervention was reported.The customer stated that 4 catheters units was occluded, they were not bent.Tests were performed and the pump was ok.The device will be returned 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; * 00777-3869
• MDR Report Key: 9966114
• Report Number: 2032227-2020-103954
• Device Sequence Number: 3318707
• Product Code: OYC
• UDI-Device Identifier: 00613994622570
• UDI-Public: (01)00613994622570
• 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): 04/15/2020

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-722NAL
• Device Catalogue Number: MMT-722NAL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1