MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Model Number MMT-723LNAS

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

Patient Problems Hypoglycemia (1912); Low Blood Pressure/ Hypotension (1914); Electrolyte Imbalance (2196)

Event Date 10/10/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The customer reported via phone call that they were hospitalized low blood glucose on (b)(6) 2021.Blood glucose level at the time of the incident was 37 mg/dl.Customer stated that she went to use bathroom and fell.Customer hurt her knee and woke up in hospital.Customer stated that they were hospitalized for four days and no heart beat.Customer reported that had no electrolytes to carry insulin and no pulse with low blood glucose.Customer was treated with sugars in hospital.Drive support cap was normal.Customer was using insulin pump within 48 hours of high blood glucose incident.The insulin pump will not be returned for analysis.

Manufacturer Narrative

Date of event information has been updated and provided with this report.

• Brand Name: PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS
• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; 7635140379
• MDR Report Key: 12702710
• MDR Text Key: 278525399
• Report Number: 2032227-2021-210729
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 000000763000161132
• UDI-Public: (01)000000763000161132
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-723LNAS
• Device Catalogue Number: MMT-723LNAS
• Device Lot Number: A7723LNASJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2020
• 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-332-RSVR, UNOMED SET.; FRN-MMT-332-RSVR, UNOMED SET.
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 125 KG