MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAH; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number	MMT-522NAH
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The insulin pump was received with a detached end cap.Unable to perform the displacement test, rewind, basic occlusion test, occlusion test, prime and compromised forced sensor system verify excessive no delivery and motor error alarms due to detached end cap.
Event or Problem Description
The customer reported via phone call that their device experience more than one motor error alarm within the last thirty days.Report does not state whether the reservoir is able to lock into place.The customer¿s blood glucose level at the time of the incident is unknown.Customer was advice disconnect from device and to refer to their healthcare provider¿s instructions.No further details or information available.The device will be returned for analysis.

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAH
• 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: 8123286
• Report Number: 2032227-2018-69463
• Device Sequence Number: 11166812
• Product Code: OYC
• UDI-Device Identifier: 00613994622686
• UDI-Public: (01)00613994622686
• Combination Product (Y/N): N
• 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): 12/02/2018

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-522NAH
• Device Catalogue Number: MMT-522NAH
• Device Lot Number: A2522NAHJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 60