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

Model Number	MMT-522NAS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/27/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Unit passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and dat test at 0.08745 inches.The stop (idle) current and run current measurement tests are within specification.Unit also passed self test, off no power alarm test and a21 error test.Unit had intermittent button response on the esc and act buttons due to flattened dome switches (no crease).No button error alarm noted.Unit uploaded properly using carelink.Unit had scratched case, cracked battery tube threads, cracked case at the reservoir tube window, cracked reservoir tube window, cracked reservoir tube lip and a missing end cap sticker.The test p-cap and reservoir does lock in place in the reservoir compartment.(b)(4).
Event or Problem Description
It was reported via phone call that the customer passed away in hospital.The customer was hospitalized on (b)(6) 2020.The cause of death was a brain aneurysm.The caller stated that the customer had dementia that may have led to the customer's passing.The customer¿s blood glucose was unknown at the time of death.The customer was not wearing the insulin pump at the time of death.The insulin pump had been disconnected 2 years prior to passing due to customer having dementia.The customer was not using sensors.The caller agreed to return the insulin pumps for analysis.This report is being made for the failure analysis results.The pump had intermittent button response on the esc and act buttons due to flattened dome switches (no crease).

• Brand Name: PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522NAS
• 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: 10132236
• Report Number: 2032227-2020-128043
• Device Sequence Number: 14416261
• Product Code: OYC
• UDI-Device Identifier: 00613994372055
• UDI-Public: (01)00613994372055
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-522NAS
• Device Catalogue Number: MMT-522NAS
• Device Lot Number: A4522NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK-RSVR UNOMED SET
• Outcome Attributed to Adverse Event: Death; Hospitalization
• Patient Age: 77 YR
• Patient Weight: 160