MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-523LNAS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Viral Infection (2248); Asystole (4442)

Event Date 01/18/2022

Event Type  Death  

Event Description

It was reported via phone call that the customer passed away in hospital.The customer was hospitalized on (b)(6) 2022 due to asystole, hypotension and covid -19.The cause of death was covid- 19.The caller stated that the customer had covid- 19 and two strokes that may have led to the customer's passing.The customer was not wearing the insulin pump at the time of death.The customer was not using sensors.The insulin pump had been disconnected 4 years prior to passing.It is unknown if the caller will return the insulin pump for analysis.

Manufacturer Narrative

S/w 3.0b.On (b)(6) 2022 the customer passed away.The pump passed the functional test, including the displacement test, rewind, basic occlusion test, occlusion test, prime/a33 test, excessive no delivery test and dat at 0.0873 inches.The stop (idle) current and run current measurement tests are within specification.The pump also passed self test, off no power alarm test and a21 error test.The pump had intermittent button response on the esc, act, up arrow and down arrow buttons due to flattened dome switched (no crease).No button error alarm noted during testing.There was no data listed on the event date in the pump's alarm history screen or in the formatted history file.Unable to confirm time/date of alarm in the pump's alarm history screen or in the formatted history file.The following were noted during visual inspection: minor scratched display window, scratched case, cracked reservoir tube and cracked reservoir tube lip.The test p-cap and reservoir does lock in place in the reservoir compartment.History download was successful using thds and carelink upload was successful.The pump did not have a battery installed when received.Please see below when reviewing the history download.There is no data available due to the pump was stored for an extended period without a battery.The pump passed the functional testing.However, the pump had intermittent buttons due to flattened dome switches on the keypad assembly was confirmed.(b)(4).

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523LNAS
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635140379
• MDR Report Key: 14069478
• MDR Text Key: 288975180
• Report Number: 2032227-2022-177379
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 0000006431695138
• UDI-Public: (01)0000006431695138
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: MMT-523LNAS
• Device Catalogue Number: MMT-523LNAS
• Device Lot Number: A4523LNASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 04/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FRN-MMT-326A-RSVR, UNOMED SET
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 145